Trial Outcomes & Findings for Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis (NCT NCT03375047)

Last Updated: 2026-02-09

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily had a causal relationship with the study treatment. A serious adverse event (SAE) was any untoward medical occurrence (whether considered to be related to study treatment or not) that at any dose: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital abnormality/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of study treatment up to 48 weeks (end of follow-up period) after the last dose of study treatment administration.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

42 participants

Primary outcome timeframe

From the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341)

Results posted on

2026-02-09

Participant Flow

The study was conducted at 16 active centers. A total of 53 participants were screened from 10 May 2018 to 22 February 2021, of which 11 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.

Study consisted of 4 parts: Part A-single ascending dose (SAD), Part B-multiple ascending dose (MAD), Part C (bronchoscopy groups) and Part D (daily dosing). A total of 42 participants were randomized (3:1 ratio) in Parts A, B and D to receive either MRT5005 or placebo. Part C was removed from protocol in 3rd amendment (dated 29 July 2019) prior to any participant enrollment in Part C. Participants were allowed to take part in 1 part of study only and results of Parts A, B and D were reported.

Participant milestones

Participant milestones
Measure	Part D: Placebo Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.	Part A - SAD Group 1: MRT5005 8 mg Participants received single dose of MRT5005 8 milligrams (mg) by nebulization on Day 1.	Part A - SAD Group 2: MRT5005 16 mg Participants received single dose of MRT5005 16 mg by nebulization on Day 1.	Part A - SAD Group 3: MRT5005 20 mg Participants received single dose of MRT5005 20 mg by nebulization on Day 1.	Part A - SAD Group 4: MRT5005 24 mg Participants received single dose of MRT5005 24 mg by nebulization on Day 1.	Part A - SAD Groups: Pooled Placebo Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Part B - MAD Group 1: MRT5005 8 mg Participants received MRT5005 8 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 2: MRT5005 12 mg Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 16 mg Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 4: MRT5005 20 mg Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	Part D: MRT5005 4 mg Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.
Overall Study STARTED	2	3	3	3	3	4	3	3	4	3	5	6
Overall Study COMPLETED	2	3	3	2	3	4	3	3	3	3	4	6
Overall Study NOT COMPLETED	0	0	0	1	0	0	0	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - SAD Group 3: MRT5005 20 mg Participants received single dose of MRT5005 20 mg by nebulization on Day 1.	Part B - MAD Group 3: MRT5005 16 mg Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.
Overall Study Pregnancy	1	0	0
Overall Study Adverse Event	0	1	0
Overall Study Site closure due to Coronavirus disease 2019 pandemic	0	0	1

Baseline Characteristics

Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - SAD Group 1: MRT5005 8 mg n=3 Participants Participants received single dose of MRT5005 8 mg by nebulization on Day 1.	Part A - SAD Group 2: MRT5005 16 mg n=3 Participants Participants received single dose of MRT5005 16 mg by nebulization on Day 1.	Part A - SAD Group 3: MRT5005 20 mg n=3 Participants Participants received single dose of MRT5005 20 mg by nebulization on Day 1.	Part A - SAD Group 4: MRT5005 24 mg n=3 Participants Participants received single dose of MRT5005 24 mg by nebulization on Day 1.	Part A - SAD Groups: Pooled Placebo n=4 Participants Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Part B - MAD Group 1: MRT5005 8 mg n=3 Participants Participants received MRT5005 8 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 2: MRT5005 12 mg n=3 Participants Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 16 mg n=4 Participants Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 4: MRT5005 20 mg n=3 Participants Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo n=5 Participants Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	Part D: MRT5005 4 mg n=6 Participants Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.	Part D: Placebo n=2 Participants Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=1267 Participants	0 Participants n=127 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=2036 Participants	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=49 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=41 Participants	3 Participants n=1581 Participants	3 Participants n=4626 Participants	3 Participants n=1267 Participants	4 Participants n=127 Participants	3 Participants n=19 Participants	3 Participants n=58 Participants	4 Participants n=2036 Participants	3 Participants n=20 Participants	4 Participants n=5 Participants	6 Participants n=49 Participants	2 Participants n=10 Participants	41 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=1267 Participants	0 Participants n=127 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=2036 Participants	0 Participants n=20 Participants	1 Participants n=5 Participants	0 Participants n=49 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Sex: Female, Male Female	0 Participants n=41 Participants	1 Participants n=1581 Participants	2 Participants n=4626 Participants	1 Participants n=1267 Participants	2 Participants n=127 Participants	3 Participants n=19 Participants	1 Participants n=58 Participants	3 Participants n=2036 Participants	1 Participants n=20 Participants	3 Participants n=5 Participants	5 Participants n=49 Participants	1 Participants n=10 Participants	23 Participants n=20 Participants
Sex: Female, Male Male	3 Participants n=41 Participants	2 Participants n=1581 Participants	1 Participants n=4626 Participants	2 Participants n=1267 Participants	2 Participants n=127 Participants	0 Participants n=19 Participants	2 Participants n=58 Participants	1 Participants n=2036 Participants	2 Participants n=20 Participants	2 Participants n=5 Participants	1 Participants n=49 Participants	1 Participants n=10 Participants	19 Participants n=20 Participants
Race/Ethnicity, Customized White	3 Participants n=41 Participants	3 Participants n=1581 Participants	3 Participants n=4626 Participants	3 Participants n=1267 Participants	3 Participants n=127 Participants	3 Participants n=19 Participants	3 Participants n=58 Participants	4 Participants n=2036 Participants	3 Participants n=20 Participants	5 Participants n=5 Participants	6 Participants n=49 Participants	2 Participants n=10 Participants	41 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=1267 Participants	1 Participants n=127 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=2036 Participants	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=49 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341)

Population: The Safety analysis set included all randomized participants who received study treatment.

Outcome measures

Outcome measures
Measure	Part A - SAD Group 2: MRT5005 16 mg n=3 Participants Participants received single dose of MRT5005 16 mg by nebulization on Day 1.	Part A - SAD Group 3: MRT5005 20 mg n=3 Participants Participants received single dose of MRT5005 20 mg by nebulization on Day 1.	Part A - SAD Group 4: MRT5005 24 mg n=3 Participants Participants received single dose of MRT5005 24 mg by nebulization on Day 1.	Part A - SAD Group 1: MRT5005 8 mg n=3 Participants Participants received single dose of MRT5005 8 mg by nebulization on Day 1.	Part A - SAD Groups: Pooled Placebo n=4 Participants Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Part B - MAD Group 1: MRT5005 8 mg n=3 Participants Participants received MRT5005 8 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 2: MRT5005 12 mg n=3 Participants Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 16 mg n=4 Participants Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 4: MRT5005 20 mg n=3 Participants Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo n=5 Participants Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	Part D: MRT5005 4 mg n=6 Participants Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.	Part D: Placebo n=2 Participants Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.
Parts A, B and D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events Any TEAE	3 Participants	3 Participants	3 Participants	3 Participants	4 Participants	3 Participants	3 Participants	4 Participants	3 Participants	5 Participants	6 Participants	2 Participants
Parts A, B and D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events Any Serious TEAE	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Part A:BL, D1(8hPD), D2(24hPD), D3, D8, D15 and D29; Part B:BL, D1(6hPD), D2, D8(PrD and 6hPD), D9, D15(PrD and 6hPD), D16, D22(PrD and 6hPD), D23, D29(PrD and 6hPD), D30, D36, D43 and D57; Part D:BL, D1(2hPD), PrD on D2, D3, D4 and D5, D11, D18 and D32

Population: The Safety analysis set included all randomized participants who received study treatment. Only those participants with data collected at specified timepoints are reported. '0' in the number analyzed field denotes that the specific time point category is not applicable to the respective reporting arm.

Spirometry was performed according to the guidelines published by the American Thoracic Society for standardization of spirometry. The ppFEV1 was assessed during the spirometry testing. For Parts A and B, the baseline value was defined as the average of the results from testing on Day -1 and at pre-dose on Day 1. For Part D, the baseline value was defined as the result from testing pre-dose on Day 1. Here, Baseline= BL, Day= D, pre-dose= PrD, hours post dose= hPD.

Outcome measures

Outcome measures
Measure	Part A - SAD Group 2: MRT5005 16 mg n=3 Participants Participants received single dose of MRT5005 16 mg by nebulization on Day 1.	Part A - SAD Group 3: MRT5005 20 mg n=3 Participants Participants received single dose of MRT5005 20 mg by nebulization on Day 1.	Part A - SAD Group 4: MRT5005 24 mg n=3 Participants Participants received single dose of MRT5005 24 mg by nebulization on Day 1.	Part A - SAD Group 1: MRT5005 8 mg n=3 Participants Participants received single dose of MRT5005 8 mg by nebulization on Day 1.	Part A - SAD Groups: Pooled Placebo n=4 Participants Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Part B - MAD Group 1: MRT5005 8 mg n=3 Participants Participants received MRT5005 8 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 2: MRT5005 12 mg n=3 Participants Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 16 mg n=4 Participants Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 4: MRT5005 20 mg n=3 Participants Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo n=5 Participants Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	Part D: MRT5005 4 mg n=6 Participants Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.	Part D: Placebo n=2 Participants Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 1: 2 hours post-dose	—	—	—	—	—	—	—	—	—	—	5.1117 percent predicted FEV1 Standard Deviation 3.75481	-2.4150 percent predicted FEV1 Standard Deviation 1.23744
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 1: 6 hours post-dose	—	—	—	—	—	-2.7017 percent predicted FEV1 Standard Deviation 3.37188	-0.3417 percent predicted FEV1 Standard Deviation 2.17959	-0.0062 percent predicted FEV1 Standard Deviation 2.66067	-1.9533 percent predicted FEV1 Standard Deviation 8.52538	1.8400 percent predicted FEV1 Standard Deviation 4.62365	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 1: 8 hours post-dose	7.2233 percent predicted FEV1 Standard Deviation 7.29017	1.1067 percent predicted FEV1 Standard Deviation 1.91247	2.4525 percent predicted FEV1 Standard Deviation 0.44194	3.6550 percent predicted FEV1 Standard Deviation 0.94230	1.1088 percent predicted FEV1 Standard Deviation 3.58541	—	—	—	—	—	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 2: Pre-dose	—	—	—	—	—	—	—	—	—	—	3.7300 percent predicted FEV1 Standard Deviation 6.24287	-0.1600 percent predicted FEV1 Standard Deviation 4.11536
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 2	11.2100 percent predicted FEV1 Standard Deviation 10.32509	4.0967 percent predicted FEV1 Standard Deviation 4.74504	8.6233 percent predicted FEV1 Standard Deviation 11.20869	2.7750 percent predicted FEV1 Standard Deviation 1.84369	0.1863 percent predicted FEV1 Standard Deviation 2.04118	-2.2383 percent predicted FEV1 Standard Deviation 2.84509	-0.2317 percent predicted FEV1 Standard Deviation 0.75466	1.7013 percent predicted FEV1 Standard Deviation 2.56612	2.0067 percent predicted FEV1 Standard Deviation 2.48702	2.2360 percent predicted FEV1 Standard Deviation 4.56081	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 3: Pre-dose	—	—	—	—	—	—	—	—	—	—	2.7583 percent predicted FEV1 Standard Deviation 7.60588	-1.8350 percent predicted FEV1 Standard Deviation 0.65761
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 3	11.3767 percent predicted FEV1 Standard Deviation 5.14516	2.3700 percent predicted FEV1 Standard Deviation 5.72278	6.5800 percent predicted FEV1 Standard Deviation 4.81868	3.4183 percent predicted FEV1 Standard Deviation 2.29152	-1.6687 percent predicted FEV1 Standard Deviation 3.21471	—	—	—	—	—	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 4: Pre-dose	—	—	—	—	—	—	—	—	—	—	1.8367 percent predicted FEV1 Standard Deviation 7.00783	2.0050 percent predicted FEV1 Standard Deviation 3.38704
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 5: Pre-dose	—	—	—	—	—	—	—	—	—	—	2.7833 percent predicted FEV1 Standard Deviation 5.62575	0.9100 percent predicted FEV1 Standard Deviation 4.53963
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 8: Pre-dose	—	—	—	—	—	-0.9883 percent predicted FEV1 Standard Deviation 0.65929	-0.8617 percent predicted FEV1 Standard Deviation 2.50250	1.9033 percent predicted FEV1 Standard Deviation 3.87243	-5.0133 percent predicted FEV1 Standard Deviation 6.39082	4.8563 percent predicted FEV1 Standard Deviation 3.87653	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 8: 6 hours post-dose	—	—	—	—	—	-3.0250 percent predicted FEV1 Standard Deviation 2.66540	0.7650 percent predicted FEV1 Standard Deviation 4.12427	2.6400 percent predicted FEV1 Standard Deviation 3.60712	-5.2500 percent predicted FEV1 Standard Deviation 13.55809	1.7488 percent predicted FEV1 Standard Deviation 4.61824	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 8	9.1867 percent predicted FEV1 Standard Deviation 1.78340	0.8533 percent predicted FEV1 Standard Deviation 0.96144	2.2867 percent predicted FEV1 Standard Deviation 3.15587	-1.2350 percent predicted FEV1 Standard Deviation 3.02842	-0.9512 percent predicted FEV1 Standard Deviation 3.31965	—	—	—	—	—	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 9	—	—	—	—	—	-0.2550 percent predicted FEV1 Standard Deviation 3.32058	-1.9250 percent predicted FEV1 Standard Deviation 1.44439	0.9800 percent predicted FEV1 Standard Deviation 2.77307	-0.3067 percent predicted FEV1 Standard Deviation 3.83939	2.4963 percent predicted FEV1 Standard Deviation 3.58692	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 11	—	—	—	—	—	—	—	—	—	—	1.0567 percent predicted FEV1 Standard Deviation 2.53699	-0.8450 percent predicted FEV1 Standard Deviation 3.14663
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 15: Pre-dose	—	—	—	—	—	1.4783 percent predicted FEV1 Standard Deviation 4.88812	-2.2750 percent predicted FEV1 Standard Deviation 3.35929	3.2767 percent predicted FEV1 Standard Deviation 2.85037	-7.0867 percent predicted FEV1 Standard Deviation 3.29160	0.2438 percent predicted FEV1 Standard Deviation 4.78050	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 15	5.5633 percent predicted FEV1 Standard Deviation 1.21378	-2.3233 percent predicted FEV1 Standard Deviation 1.80292	0.4833 percent predicted FEV1 Standard Deviation 5.25663	-0.2383 percent predicted FEV1 Standard Deviation 3.63470	0.5763 percent predicted FEV1 Standard Deviation 1.57608	—	—	—	—	—	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 15: 6 hours post-dose	—	—	—	—	—	-1.9083 percent predicted FEV1 Standard Deviation 4.30519	-0.8350 percent predicted FEV1 Standard Deviation 0.48210	3.5100 percent predicted FEV1 Standard Deviation 2.36540	-3.0233 percent predicted FEV1 Standard Deviation 10.09021	3.6763 percent predicted FEV1 Standard Deviation 2.82176	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 16	—	—	—	—	—	-2.6017 percent predicted FEV1 Standard Deviation 3.59609	-4.4217 percent predicted FEV1 Standard Deviation 0.24322	1.6800 percent predicted FEV1 Standard Deviation 1.39796	-3.9033 percent predicted FEV1 Standard Deviation 6.24793	2.5388 percent predicted FEV1 Standard Deviation 5.43594	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 18	—	—	—	—	—	—	—	—	—	—	0.1600 percent predicted FEV1 Standard Deviation 1.78332	-1.3700 percent predicted FEV1 Standard Deviation 0.77782
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 22: Pre-dose	—	—	—	—	—	-3.4417 percent predicted FEV1 Standard Deviation 0.79907	-2.5317 percent predicted FEV1 Standard Deviation 3.12407	1.0433 percent predicted FEV1 Standard Deviation 2.61190	-3.5567 percent predicted FEV1 Standard Deviation 3.44181	1.6863 percent predicted FEV1 Standard Deviation 6.44122	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 22: 6 hours post-dose	—	—	—	—	—	-4.4150 percent predicted FEV1 Standard Deviation 1.30844	-3.1183 percent predicted FEV1 Standard Deviation 2.60335	1.4033 percent predicted FEV1 Standard Deviation 2.70263	-3.2933 percent predicted FEV1 Standard Deviation 8.33613	4.9788 percent predicted FEV1 Standard Deviation 8.56683	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 23	—	—	—	—	—	-2.5650 percent predicted FEV1 Standard Deviation 2.27414	-3.5550 percent predicted FEV1 Standard Deviation 1.42163	2.6233 percent predicted FEV1 Standard Deviation 5.05601	-3.1900 percent predicted FEV1 Standard Deviation 6.42324	0.7463 percent predicted FEV1 Standard Deviation 8.20475	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 29: Pre-dose	—	—	—	—	—	-4.1350 percent predicted FEV1 Standard Deviation 1.25896	-2.9725 percent predicted FEV1 Standard Deviation 3.42593	0.1667 percent predicted FEV1 Standard Deviation 1.82582	-5.7133 percent predicted FEV1 Standard Deviation 2.39036	2.9863 percent predicted FEV1 Standard Deviation 9.33491	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 29: 6 hours post-dose	—	—	—	—	—	-4.7350 percent predicted FEV1 Standard Deviation 0.70326	0.3125 percent predicted FEV1 Standard Deviation 0.06010	0.8467 percent predicted FEV1 Standard Deviation 1.79528	0.0567 percent predicted FEV1 Standard Deviation 11.03200	2.7563 percent predicted FEV1 Standard Deviation 4.51659	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 29	4.6633 percent predicted FEV1 Standard Deviation 4.65445	2.5133 percent predicted FEV1 Standard Deviation 5.06806	-5.2633 percent predicted FEV1 Standard Deviation 13.06648	3.0983 percent predicted FEV1 Standard Deviation 4.90188	0.7517 percent predicted FEV1 Standard Deviation 4.27498	—	—	—	—	—	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 30	—	—	—	—	—	-3.2717 percent predicted FEV1 Standard Deviation 4.61490	-4.7375 percent predicted FEV1 Standard Deviation 3.98455	4.8000 percent predicted FEV1 Standard Deviation 5.94778	1.1667 percent predicted FEV1 Standard Deviation 8.98756	0.9888 percent predicted FEV1 Standard Deviation 7.33033	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 32	—	—	—	—	—	—	—	—	—	—	4.8550 percent predicted FEV1 Standard Deviation 6.05264	-0.1150 percent predicted FEV1 Standard Deviation 4.49013
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 36	—	—	—	—	—	-0.9383 percent predicted FEV1 Standard Deviation 2.30022	-2.2975 percent predicted FEV1 Standard Deviation 2.85318	-0.7733 percent predicted FEV1 Standard Deviation 5.20926	-3.5333 percent predicted FEV1 Standard Deviation 8.93039	4.8463 percent predicted FEV1 Standard Deviation 8.26378	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 43	—	—	—	—	—	-3.2550 percent predicted FEV1 Standard Deviation 0.69262	-0.0050 percent predicted FEV1	-2.0367 percent predicted FEV1 Standard Deviation 6.75614	-3.1533 percent predicted FEV1 Standard Deviation 3.50810	5.1363 percent predicted FEV1 Standard Deviation 7.51406	—	—
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Day 57	—	—	—	—	—	-5.5517 percent predicted FEV1 Standard Deviation 4.38918	1.0750 percent predicted FEV1	1.9500 percent predicted FEV1 Standard Deviation 1.02103	-7.1667 percent predicted FEV1 Standard Deviation 9.31929	0.4288 percent predicted FEV1 Standard Deviation 5.91134	—	—

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A - SAD Group1: MRT5005 8 mg n=3 participants at risk Participants received single dose of MRT5005 8 mg by nebulization on Day1.	Part A - SAD Group 2: MRT5005 16 mg n=3 participants at risk Participants received single dose of MRT5005 16 mg by nebulization on Day1.	Part A - SAD Group 3: MRT5005 20 mg n=3 participants at risk Participants received single dose of MRT5005 20 mg by nebulization on Day1.	Part A - SAD Group 4: MRT5005 24 mg n=3 participants at risk Participants received single dose of MRT5005 24 mg by nebulization on Day1.	Part A - SAD Groups: Pooled Placebo n=4 participants at risk Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Part B - MAD Group 1: MRT5005 8 mg n=3 participants at risk Participants received MRT5005 8 mg once weekly by nebulization for 5weeks (i.e., on Day1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 2: MRT5005 12 mg n=3 participants at risk Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 16 mg n=4 participants at risk Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 20 mg n=3 participants at risk Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo n=5 participants at risk Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	Part D: MRT5005 4 mg n=6 participants at risk Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.	Part D: Placebo n=2 participants at risk Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.
Infections and infestations Infective Pulmonary Exacerbation Of Cystic Fibrosis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 2/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Immune system disorders Anaphylactic Reaction	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Calculus Urinary	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.

Other adverse events

Other adverse events
Measure	Part A - SAD Group1: MRT5005 8 mg n=3 participants at risk Participants received single dose of MRT5005 8 mg by nebulization on Day1.	Part A - SAD Group 2: MRT5005 16 mg n=3 participants at risk Participants received single dose of MRT5005 16 mg by nebulization on Day1.	Part A - SAD Group 3: MRT5005 20 mg n=3 participants at risk Participants received single dose of MRT5005 20 mg by nebulization on Day1.	Part A - SAD Group 4: MRT5005 24 mg n=3 participants at risk Participants received single dose of MRT5005 24 mg by nebulization on Day1.	Part A - SAD Groups: Pooled Placebo n=4 participants at risk Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Part B - MAD Group 1: MRT5005 8 mg n=3 participants at risk Participants received MRT5005 8 mg once weekly by nebulization for 5weeks (i.e., on Day1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 2: MRT5005 12 mg n=3 participants at risk Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 16 mg n=4 participants at risk Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Group 3: MRT5005 20 mg n=3 participants at risk Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	Part B - MAD Groups: Pooled Placebo n=5 participants at risk Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	Part D: MRT5005 4 mg n=6 participants at risk Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.	Part D: Placebo n=2 participants at risk Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.
Infections and infestations Covid-19	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Psychiatric disorders Anxiety	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Acute Sinusitis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Candida Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Chronic Sinusitis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Gastroenteritis Viral	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Infective Pulmonary Exacerbation Of Cystic Fibrosis	100.0% 3/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 8 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	75.0% 3/4 • Number of events 10 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 8 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 2/4 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 3/6 • Number of events 6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Influenza	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Mycobacterial Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Oropharyngeal Candidiasis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Otitis Media	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Pharyngitis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Pharyngitis Streptococcal	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Respiratory Tract Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Rhinovirus Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Sialoadenitis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Sinusitis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Systemic Candida	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Urinary Tract Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Viral Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Viral Rash	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Immune system disorders Allergy To Vaccine	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Immune system disorders Drug Hypersensitivity	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Immune system disorders Hypersensitivity	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Decreased Appetite	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Increased Appetite	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Psychiatric disorders Attention Deficit Hyperactivity Disorder	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Psychiatric disorders Depression	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Psychiatric disorders Insomnia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Psychiatric disorders Sleep Disorder	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Psychiatric disorders Suicidal Ideation	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Ageusia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Anosmia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Aphasia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Disturbance In Attention	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Headache	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 10 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Hyperaesthesia	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Mental Impairment	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Migraine	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Neuropathy Peripheral	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Paraesthesia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Presyncope	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Sinus Headache	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Sleep Paralysis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Syncope	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Nervous system disorders Tremor	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Eye disorders Eye Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Eye disorders Photophobia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Eye disorders Vision Blurred	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Ear and labyrinth disorders Deafness	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Ear and labyrinth disorders Ear Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Cardiac disorders Palpitations	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Cardiac disorders Tachycardia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Vascular disorders Deep Vein Thrombosis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Vascular disorders Hyperaemia	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 3/3 • Number of events 11 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 7 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 12 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 4/4 • Number of events 8 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	60.0% 3/5 • Number of events 7 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 2/2 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Asthenia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	75.0% 3/4 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 2/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Increased Bronchial Secretion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Increased Upper Airway Secretion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Congestion	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus Discomfort	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus Hypersecretion	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiration Abnormal	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sinus Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sinus Polyp	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sputum Discoloured	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sputum Increased	66.7% 2/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	60.0% 3/5 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Congestion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Upper-Airway Cough Syndrome	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 2/4 • Number of events 6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Distension	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Pain	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Constipation	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Dental Caries	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Gastric Polyps	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Gastrointestinal Motility Disorder	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Gingival Swelling	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Hypertrophy Of Tongue Papillae	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Proctitis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Tooth Deposit	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Dermatitis Contact	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Nail Pigmentation	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Night Sweats	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Trigger Finger	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Dysuria	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Glycosuria	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Haematuria	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Polyuria	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Pregnancy, puerperium and perinatal conditions Morning Sickness	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Reproductive system and breast disorders Breast Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Reproductive system and breast disorders Dyspareunia	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Reproductive system and breast disorders Uterine Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Chest Discomfort	33.3% 1/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Chest Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Chills	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	75.0% 3/4 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Crepitations	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Feeling Abnormal	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Injection Site Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Malaise	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	100.0% 3/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	75.0% 3/4 • Number of events 5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	66.7% 2/3 • Number of events 6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Reactogenicity Event	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
General disorders Vaccination Site Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Alanine Aminotransferase Increased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Aspartate Aminotransferase Increased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Blood Creatinine Increased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Blood Uric Acid Increased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Body Temperature Increased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Breath Sounds Abnormal	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations C-Reactive Protein Increased	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Forced Expiratory Volume Decreased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Fungal Test Positive	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Heart Rate Irregular	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Hepatic Enzyme Increased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Herpes Simplex Test Positive	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Liver Function Test Abnormal	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Mycobacterium Test Positive	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Pulmonary Function Test Decreased	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Sputum Abnormal	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Streptococcus Test Positive	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Investigations Weight Decreased	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Burns First Degree	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	50.0% 1/2 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	33.3% 1/3 • Number of events 1 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/4 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/3 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/5 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/6 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.	0.00% 0/2 • Serious adverse events (AEs), other AEs and all-cause mortality (deaths) were collected from the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341) Analysis was performed on the safety analysis set.

Additional Information

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