Trial Outcomes & Findings for A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (NCT NCT03449030)

NCT ID: NCT03449030

Last Updated: 2021-03-22

Results Overview

DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count \[ANC\] less than (\<) 500 cells/cubic millimeter \[mm\^3\]), thrombocytopenia (platelets \<25,000/mm\^3), febrile neutropenia (ANC \<1000/mm\^3) with fever (greater than \[\>\] 38.3 degree Celsius or sustained temperature of greater than or equal to (\>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (\<1 week) Grade 3 fatigue.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline up to Month 22
• Results posted on: 2021-03-22

Participant Flow

Participants took part in the study at 5 investigative sites in the United States from 23 April 2018 to 27 February 2020.

Participants with advanced gastrointestinal (GI) cancers expressing guanylyl cyclase C (GCC) were enrolled in this study to receive TAK-164, every 3 weeks in Part A (Dose Escalation) of the study. Study was terminated after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.

Participant milestones

Measure	Part A: TAK-164 0.004 mg/kg TAK-164 0.004 milligram per kilogram (mg/kg), intravenous infusion, on Day 1 of each 21-day treatment cycle until progressive disease (PD), unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Study STARTED	1	1	1	5	7	7	2	3	3	1
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	1	1	5	7	7	2	3	3	1

Reasons for withdrawal

Measure	Part A: TAK-164 0.004 mg/kg TAK-164 0.004 milligram per kilogram (mg/kg), intravenous infusion, on Day 1 of each 21-day treatment cycle until progressive disease (PD), unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Study Withdrawal by Subject	0	0	0	1	1	1	1	2	0	0
Overall Study Symptomatic Deterioration	0	1	0	0	0	1	1	0	2	0
Overall Study Progressive Disease	1	0	1	4	5	3	0	1	1	1
Overall Study Adverse Event	0	0	0	0	0	2	0	0	0	0
Overall Study Death	0	0	0	0	1	0	0	0	0	0

Baseline Characteristics

A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)

Baseline characteristics by cohort

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Total n=31 Participants Total of all reporting groups
Age, Continuous	72.0 years STANDARD_DEVIATION NA • n=5 Participants	52.0 years STANDARD_DEVIATION NA • n=7 Participants	59.0 years STANDARD_DEVIATION NA • n=5 Participants	55.2 years STANDARD_DEVIATION 8.14 • n=4 Participants	57.1 years STANDARD_DEVIATION 8.36 • n=21 Participants	48.0 years STANDARD_DEVIATION 13.11 • n=8 Participants	53.0 years STANDARD_DEVIATION 14.14 • n=8 Participants	65.3 years STANDARD_DEVIATION 3.21 • n=24 Participants	48.0 years STANDARD_DEVIATION 3.61 • n=42 Participants	39.0 years STANDARD_DEVIATION NA • n=42 Participants	54.2 years STANDARD_DEVIATION 10.59 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	18 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	13 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	7 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	29 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	25 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	31 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline up to Month 22

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count [ANC] less than (<) 500 cells/cubic millimeter [mm^3]), thrombocytopenia (platelets <25,000/mm^3), febrile neutropenia (ANC <1000/mm^3) with fever (greater than [>] 38.3 degree Celsius or sustained temperature of greater than or equal to (>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (<1 week) Grade 3 fatigue.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Percentage of Participants With Adverse Events (AEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: Death related AE. Higher grade indicates more severe condition.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Percentage of Participants With Grade 3 or Above AEs	0 percentage of participants	100 percentage of participants	100 percentage of participants	60 percentage of participants	14.3 percentage of participants	71.4 percentage of participants	50.0 percentage of participants	100 percentage of participants	100 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Percentage of Participants With Drug-related AEs	100 percentage of participants	0 percentage of participants	100 percentage of participants	100 percentage of participants	85.7 percentage of participants	71.4 percentage of participants	50.0 percentage of participants	66.7 percentage of participants	66.7 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Percentage of Participants With Drug-related Grade 3 or Above AEs	0 percentage of participants	0 percentage of participants	100 percentage of participants	20.0 percentage of participants	14.3 percentage of participants	42.9 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	66.7 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Percentage of Participants With Serious Adverse Events (SAEs)	0 percentage of participants	100 percentage of participants	0 percentage of participants	60 percentage of participants	0 percentage of participants	42.9 percentage of participants	50.0 percentage of participants	66.7 percentage of participants	66.7 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Percentage of Participants With AEs Leading to Discontinuation	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	28.6 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline up to Month 22

Population: The safety population was defined as all participants who received at least 1 dose of study drug.

RP2D was the highest safe dose that could be applied to the expansion phase.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=31 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Recommended Phase 2 Dose (RP2D) of TAK-164	0.064 mg/kg	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)

Population: Pharmacokinetic (PK) analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)

Population: PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)

Population: PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)

Population: PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment until the start of subsequent anti cancer therapy ( up to Month 22)

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment.

ORR was assessed by the investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=6 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=5 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=2 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=1 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Response Rate (ORR)	0 percentage of participants Interval 0.0 to 97.5	100 percentage of participants Interval 2.5 to 100.0	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 84.2	0 percentage of participants Interval 0.0 to 84.2	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Baseline up to Month 22

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-Baseline disease assessment.

DCR was defined as the percentage of participants with CR, PR or stable disease (SD). DCR was assessed based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=6 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=5 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=2 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=1 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Disease Control Rate (DCR)	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	40.0 percentage of participants Interval 5.3 to 85.3	50.0 percentage of participants Interval 11.8 to 88.2	40.0 percentage of participants Interval 5.3 to 85.3	50.0 percentage of participants Interval 1.3 to 98.7	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: From the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first (up to 22 months)

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events CR or PR.

DOR was defined as the time from the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameters. PD was >=20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Duration of Response (DOR)	—	NA months Median, lower and upper limit of 95% CI could not be calculated because none of the participant had an event (PD or death)	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first (up to 22 months)

Population: The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events (PD or/and death).

PFS was defined as the time from date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first according to modified RECIST version 1.1 criteria. PD was >= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD. PFS was censored at the last response assessment that is stable disease or better, prior to receipt of subsequent anticancer therapy, if applicable. Participants with no post-baseline assessments was censored at Day 1.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=4 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=6 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=3 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=1 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=2 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=1 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Progression-free Survival (PFS)	2.79 months Lower and upper limit of 95% CI could not be calculated because only one participant had an event.	—	6.24 months Lower and upper limit of 95% CI could not be calculated because only one participant had an event.	1.35 months Interval 0.59 to Upper limit of 95% CI could not be calculated because insufficient number of participants had an event.	1.91 months Interval 1.22 to 3.48	1.58 months Interval 1.08 to 1.58	1.41 months Lower and upper limit of 95% CI could not be calculated because only one participant had an event.	1.81 months Interval 1.25 to 2.37	1.05 months Lower and upper limit of 95% CI could not be calculated because only one participant had an event.	1.18 months Lower and upper limit of 95% CI could not be calculated because only one participant had an event.

SECONDARY outcome

Timeframe: Baseline up to Month 22

Population: The immunogenicity evaluable population was defined as all participants with a baseline immunogenicity assessment and at least 1 postbaseline immunogenicity assessment.

Outcome measures

Measure	Part A: TAK-164 0.004 mg/kg n=1 Participants TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 Participants TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 Participants TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 Participants TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 Participants TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=6 Participants TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 Participants TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=1 Participants TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 Participants TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 Participants TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Number of Participants With Positive Antidrug Antibody (ADA) Levels in Serum	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Part A: TAK-164 0.004 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A: TAK-164 0.008 mg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A: TAK-164 0.016 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A: TAK-164 0.032 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: TAK-164 0.064 mg/kg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 1 deaths

Part A: TAK-164 0.12 mg/kg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: TAK-164 0.16 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: TAK-164 0.19 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A: TAK-164 0.25 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: TAK-164 0.32 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: TAK-164 0.004 mg/kg n=1 participants at risk TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 participants at risk TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 participants at risk TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 participants at risk TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 participants at risk TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 participants at risk TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 participants at risk TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 participants at risk TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 participants at risk TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 participants at risk TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Nausea	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Hepatobiliary disorders Hepatic failure	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Blood bilirubin increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Platelet count decreased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Pneumonia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Sepsis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Cardiac disorders Arrhythmia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Pyrexia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.

Other adverse events

Measure	Part A: TAK-164 0.004 mg/kg n=1 participants at risk TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.008 mg/kg n=1 participants at risk TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.016 mg/kg n=1 participants at risk TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.032 mg/kg n=5 participants at risk TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.064 mg/kg n=7 participants at risk TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.12 mg/kg n=7 participants at risk TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.16 mg/kg n=2 participants at risk TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.19 mg/kg n=3 participants at risk TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.25 mg/kg n=3 participants at risk TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.	Part A: TAK-164 0.32 mg/kg n=1 participants at risk TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	60.0% 3/5 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Nausea	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	40.0% 2/5 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	40.0% 2/5 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Constipation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Fatigue	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	80.0% 4/5 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	57.1% 4/7 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Pyrexia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Chills	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Oedema peripheral	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Platelet count decreased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 5/5 • Number of events 6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	71.4% 5/7 • Number of events 11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 3/3 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	60.0% 3/5 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	57.1% 4/7 • Number of events 6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 3/3 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	60.0% 3/5 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 3/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Blood bilirubin increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	40.0% 2/5 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 3/3 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations International normalised ratio increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Lymphocyte count decreased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Neutrophil count decreased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations White blood cell count decreased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Weight decreased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 3/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	60.0% 3/5 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	57.1% 4/7 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	42.9% 3/7 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	66.7% 2/3 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Haematuria	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Proteinuria	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Nervous system disorders Headache	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Nervous system disorders Dizziness	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Urinary tract infection	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Psychiatric disorders Insomnia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	28.6% 2/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Psychiatric disorders Confusional state	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Vascular disorders Hypotension	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Vascular disorders Hypertension	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Abdominal wall mass	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Colitis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Chest pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Extravasation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Influenza like illness	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Infusion site haemorrhage	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Injection site bruising	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Mucosal inflammation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
General disorders Gait disturbance	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Blood creatinine increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Investigations Lipase increased	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Bladder discomfort	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Dysuria	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Hydronephrosis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Urinary hesitation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Renal and urinary disorders Urinary retention	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Nervous system disorders Dysgeusia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Nervous system disorders Somnolence	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Nervous system disorders Taste disorder	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Candida infection	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Ear infection	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Oral candidiasis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Pneumonia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Psychiatric disorders Hallucination	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Psychiatric disorders Agitation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Skin swelling	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Cardiac disorders Tachycardia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Hepatobiliary disorders Cholecystitis	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Eye disorders Eye haemorrhage	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	14.3% 1/7 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.	0.00% 0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER