Trial Outcomes & Findings for Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (NCT NCT03307785)

NCT ID: NCT03307785

Last Updated: 2025-11-25

Results Overview

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2025-11-25

Participant Flow

A total of 60 participants were enrolled in the study and 2 participants who originally signed inform consent form (ICF) withdrew their consent shortly from study before treatment assignment and a total of 58 participants were part of the study.

The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. Main Study Phase was planned to be a nine-part study with Parts A to I. However, Parts G, H and I were not initiated due to business strategic reason. In PACT phase those participants benefiting from treatment continued to receive study drug until discontinuation or withdrawal from study.

Participant milestones

Measure	Main Study: Part A: TSR-042 and Niraparib 200 mg QD Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.	Main Study: Part A: TSR-042 and Niraparib 300 mg QD Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part E: TSR-042 and Carboplatin-pemetrexed Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).	Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).	Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.	Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.	Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).	PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Main Study: Part A: Up to 28.5 Months STARTED	16	6	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months NOT COMPLETED	16	6	0	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months STARTED	0	0	14	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months NOT COMPLETED	0	0	14	0	0	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months STARTED	0	0	0	6	7	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months NOT COMPLETED	0	0	0	6	7	0	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months STARTED	0	0	0	0	0	6	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months NOT COMPLETED	0	0	0	0	0	6	0	0	0	0	0	0	0
Main Study: Part E: Up to 4.4 Months STARTED	0	0	0	0	0	0	2	0	0	0	0	0	0
Main Study: Part E: Up to 4.4 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part E: Up to 4.4 Months NOT COMPLETED	0	0	0	0	0	0	2	0	0	0	0	0	0
Main Study: Part F: Up to 3.5 Months STARTED	0	0	0	0	0	0	0	1	0	0	0	0	0
Main Study: Part F: Up to 3.5 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part F: Up to 3.5 Months NOT COMPLETED	0	0	0	0	0	0	0	1	0	0	0	0	0
Main Study: Part G: Up to 24 Months STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part G: Up to 24 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part G: Up to 24 Months NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part H: Up to 24 Months STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part H: Up to 24 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part H: Up to 24 Months NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part I: Up to 24 Months STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part I: Up to 24 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part I: Up to 24 Months NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
PACT Phase: Up to 19 Months STARTED	0	0	0	0	0	0	0	0	0	0	0	2	1
PACT Phase: Up to 19 Months COMPLETED	0	0	0	0	0	0	0	0	0	0	0	2	0
PACT Phase: Up to 19 Months NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	1

Reasons for withdrawal

Measure	Main Study: Part A: TSR-042 and Niraparib 200 mg QD Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.	Main Study: Part A: TSR-042 and Niraparib 300 mg QD Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part E: TSR-042 and Carboplatin-pemetrexed Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).	Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).	Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.	Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.	Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).	PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Main Study: Part A: Up to 28.5 Months Disease progression	2	0	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months Withdrawal by Subject	7	1	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months Death	4	4	0	0	0	0	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months Physician Decision	3	1	0	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months Disease progression	0	0	2	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months Death	0	0	7	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months Withdrawal by Subject	0	0	2	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months Transitioned to PACT phase	0	0	2	0	0	0	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months Physician Decision	0	0	1	0	0	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months Physician Decision	0	0	0	3	1	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months Death	0	0	0	2	5	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months Withdrawal by Subject	0	0	0	1	0	0	0	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months Went on Another Clinical Trial	0	0	0	0	1	0	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months Physician Decision	0	0	0	0	0	2	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months Death	0	0	0	0	0	1	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months Withdrawal by Subject	0	0	0	0	0	1	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months Transitioned to PACT phase	0	0	0	0	0	1	0	0	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months Completed EOT and Began New Study	0	0	0	0	0	1	0	0	0	0	0	0	0
Main Study: Part E: Up to 4.4 Months Death	0	0	0	0	0	0	1	0	0	0	0	0	0
Main Study: Part E: Up to 4.4 Months Physician Decision	0	0	0	0	0	0	1	0	0	0	0	0	0
Main Study: Part F: Up to 3.5 Months Physician Decision	0	0	0	0	0	0	0	1	0	0	0	0	0
PACT Phase: Up to 19 Months Death	0	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Baseline characteristics by cohort

Measure	Main Study: Part A: TSR-042 and Niraparib 200 mg QD n=16 Participants Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.	Main Study: Part A: TSR-042 and Niraparib 300 mg QD n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part E: TSR-042 and Carboplatin-pemetrexed n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).	Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).	Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.	Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.	Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).	Total n=58 Participants Total of all reporting groups
Age, Customized 18-64 years	8 Participants n=45 Participants	3 Participants n=12929 Participants	5 Participants n=6349 Participants	4 Participants n=4548 Participants	6 Participants n=28448 Participants	2 Participants n=10 Participants	1 Participants n=1353 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	30 Participants n=110 Participants
Age, Customized 65-74 years	6 Participants n=45 Participants	1 Participants n=12929 Participants	4 Participants n=6349 Participants	2 Participants n=4548 Participants	1 Participants n=28448 Participants	3 Participants n=10 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	17 Participants n=110 Participants
Age, Customized >=75 years	2 Participants n=45 Participants	2 Participants n=12929 Participants	5 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	1 Participants n=10 Participants	1 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	11 Participants n=110 Participants
Sex: Female, Male Female	9 Participants n=45 Participants	2 Participants n=12929 Participants	8 Participants n=6349 Participants	4 Participants n=4548 Participants	7 Participants n=28448 Participants	5 Participants n=10 Participants	0 Participants n=1353 Participants	NA Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	NA Participants n=110 Participants
Sex: Female, Male Male	7 Participants n=45 Participants	4 Participants n=12929 Participants	6 Participants n=6349 Participants	2 Participants n=4548 Participants	0 Participants n=28448 Participants	1 Participants n=10 Participants	2 Participants n=1353 Participants	NA Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	NA Participants n=110 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=45 Participants	1 Participants n=12929 Participants	1 Participants n=6349 Participants	0 Participants n=4548 Participants	2 Participants n=28448 Participants	0 Participants n=10 Participants	1 Participants n=1353 Participants	NA Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	NA Participants n=110 Participants
Race/Ethnicity, Customized White	16 Participants n=45 Participants	5 Participants n=12929 Participants	13 Participants n=6349 Participants	6 Participants n=4548 Participants	5 Participants n=28448 Participants	6 Participants n=10 Participants	1 Participants n=1353 Participants	NA Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants	0 Participants n=110 Participants	NA Participants n=110 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population consisted of all participants who received any amount of study treatment.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Number of Participants With Dose-limiting Toxicity (DLT)	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Number of Participants With DLT	—	1 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Number of Participants With DLT	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Number of Participants With DLT	—	0 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Number of Participants With DLT	—	0 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Number of Participants With DLT	—	0 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 21 days

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs) Non-serious TEAEs	6 Participants	16 Participants
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs) STEAEs	4 Participants	11 Participants
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs) AESIs	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs Non-Serious TEAEs	—	14 Participants
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs STEAEs	—	9 Participants
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs AESIs	—	0 Participants

PRIMARY outcome

Timeframe: Up to 22.5 months

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs Non-serious TEAEs	7 Participants	5 Participants
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs STEAEs	3 Participants	3 Participants
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs AESIs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 9.5 months

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs Non-serious TEAEs	—	6 Participants
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs STEAEs	—	3 Participants
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs AESIs	—	0 Participants

PRIMARY outcome

Timeframe: Up to 4.4 months

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs Non-serious TEAEs	—	2 Participants
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs STEAEs	—	2 Participants
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs AESIs	—	0 Participants

PRIMARY outcome

Timeframe: Up to 3.5 months

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs Non-serious TEAEs	—	1 Participants
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs STEAEs	—	0 Participants
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs AESIs	—	0 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Objective Response Rate	0 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Objective Response Rate	—	42.9 Percentage of participants

SECONDARY outcome

Timeframe: Up to 22.5 months

Population: Safety Population.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Objective Response Rate	14.3 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 9.5 months

Population: Safety Population.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Objective Response Rate	—	50.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 4.4 months

Population: Safety Population.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Objective Response Rate	—	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 3.5 months

Population: Safety Population.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Objective Response Rate	—	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Duration of Response	NA Months Duration of response could not be calculated as no participants had a confirmed CR or PR in TSR-042 and niraparib 300 mg QD arm.	7.59 Months Interval 5.78 to 10.94

SECONDARY outcome

Timeframe: Up to approximately 66 months

Population: Safety Population.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Duration of Response	—	NA Months Median and full range were not calculable due to more than 50% censored participants in this treatment group.

SECONDARY outcome

Timeframe: Up to approximately 60 months

Population: Safety Population.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Duration of Response	NA Months Median and full range were not calculable due to more than 50% censored participants in this treatment group.	NA Months Median and full range were not calculable due to more than 50% censored participants in this treatment group.

SECONDARY outcome

Timeframe: Up to approximately 62.5 months

Population: Safety Population.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Duration of Response	—	NA Months Median and full range were not calculable due to more than 50% censored participants in this treatment group.

SECONDARY outcome

Timeframe: Up to 4.4 months

Population: Safety Population.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Duration of Response	—	NA Months Duration of response could not be calculated as no participants had a confirmed CR or PR.

SECONDARY outcome

Timeframe: Up to 3.5 months

Population: Safety Population.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Duration of Response	—	NA Months Median and full range could not be calculated as there were no confirmed CR or PR.

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Disease Control Rate	33.3 Percentage of participants	43.8 Percentage of participants

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Disease Control Rate	—	57.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 22.5 months

Population: Safety Population.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Disease Control Rate	85.7 Percentage of participants	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to 9.5 months

Population: Safety Population.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Disease Control Rate	—	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to 4.4 months

Population: Safety Population.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Disease Control Rate	—	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 3.5 months

Population: Safety Population.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Disease Control Rate	—	100 Percentage of participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Progression-free Survival	2.8 Months Interval 2.3 to 4.7	6.2 Months Interval 2.2 to 9.9

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Safety Population.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Progression-free Survival	—	17.6 Months Interval 3.9 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to 22.5 months

Population: Safety Population.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Progression-free Survival	9.1 Months Interval 8.0 to 11.1	NA Months Interval 8.5 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to 9.5 months

Population: Safety Population.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Progression-free Survival	—	7.6 Months Interval 7.4 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to 4.4 months

Population: Safety Population.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Progression-free Survival	—	NA Months Median and Inter Quartile range could not be estimated due to the low number of participants with events.

SECONDARY outcome

Timeframe: Up to 3.5 months

Population: Safety Population.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Progression-free Survival	—	NA Months Median and Inter Quartile range could not be estimated due to the low number of participant with event.

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28.5 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Number of Participants With Positive Anti-TSR-042 Antibodies	—	4 Participants

SECONDARY outcome

Timeframe: Up to 22.5 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 9.5 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Number of Participants With Positive Anti-TSR-042 Antibodies	—	0 Participants

SECONDARY outcome

Timeframe: Up to 4.4 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Number of Participants With Positive Anti-TSR-042 Antibodies	—	0 Participants

SECONDARY outcome

Timeframe: Up to 3.5 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Number of Participants With Positive Anti-TSR-042 Antibodies	—	NA Participants Data could not be calculated due to insufficient participant with data.

SECONDARY outcome

Timeframe: Up to 3.5 months

Population: Anti-drug Antibody Population.

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Number of Participants With Positive Anti-TSR-022 Antibodies	—	NA Participants Data could not be calculated due to insufficient participant with data.

SECONDARY outcome

Timeframe: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=15 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib Cycle 1, n=15,6	7.8341 Hours*microgram per milliliter Standard Deviation 4.76380	6.0430 Hours*microgram per milliliter Standard Deviation 3.43261
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib Cycle 2, n=10,3	29.3024 Hours*microgram per milliliter Standard Deviation 2.15129	14.9172 Hours*microgram per milliliter Standard Deviation 9.82689

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: AUC(0-t) of TSR-042 Cycle 5, n=8,1	141328.9288 Hours*microgram per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	137108.2574 Hours*microgram per milliliter Standard Deviation 41494.15474
Part A: AUC(0-t) of TSR-042 Cycle 11, n=5,0	—	139591.8834 Hours*microgram per milliliter Standard Deviation 53844.12650
Part A: AUC(0-t) of TSR-042 Cycle 4, n=9,4	29311.8182 Hours*microgram per milliliter Standard Deviation 16546.73177	55408.3992 Hours*microgram per milliliter Standard Deviation 21631.17124
Part A: AUC(0-t) of TSR-042 Cycle 1, n=16,6	29420.8347 Hours*microgram per milliliter Standard Deviation 9262.18751	26827.7703 Hours*microgram per milliliter Standard Deviation 9811.74994

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: AUC0-t of TSR-042 Cycle 11, n=6	—	117030.4081 Hours*microgram per milliliter Standard Deviation 33852.45635
Part B: AUC0-t of TSR-042 Cycle 1, n=14	—	28097.9846 Hours*microgram per milliliter Standard Deviation 8440.50578
Part B: AUC0-t of TSR-042 Cycle 4, n=10	—	54730.0053 Hours*microgram per milliliter Standard Deviation 15857.69305
Part B: AUC0-t of TSR-042 Cycle 5, n=9	—	124309.5455 Hours*microgram per milliliter Standard Deviation 56505.10671

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: AUC0-t of Niraparib Cycle 1, n=6,7	11.3601 Hours*microgram per milliliter Standard Deviation 5.53524	3.4513 Hours*microgram per milliliter Standard Deviation 1.23048
Part C: AUC0-t of Niraparib Cycle 2, n=4,4	24.9691 Hours*microgram per milliliter Standard Deviation 17.50367	14.7473 Hours*microgram per milliliter Standard Deviation 8.11715

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: AUC0-t of TSR-042 Cycle 1, n=6,7	26311.1789 Hours*microgram per milliliter Standard Deviation 4416.61957	29830.6542 Hours*microgram per milliliter Standard Deviation 8143.36941
Part C: AUC0-t of TSR-042 Cycle 4, n=5,7	49198.8237 Hours*microgram per milliliter Standard Deviation 12507.66126	54268.1379 Hours*microgram per milliliter Standard Deviation 14777.09545
Part C: AUC0-t of TSR-042 Cycle 5, n=5,6	131281.9046 Hours*microgram per milliliter Standard Deviation 36835.39730	137777.3188 Hours*microgram per milliliter Standard Deviation 45794.21973
Part C: AUC0-t of TSR-042 Cycle 11, n=4,2	119161.8795 Hours*microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	143070.3093 Hours*microgram per milliliter Standard Deviation 74219.00272

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: AUC0-t of TSR-042 Cycle 1, n=6	—	32819.5401 Hours*microgram per milliliter Standard Deviation 9182.44511
Part D: AUC0-t of TSR-042 Cycle 4, n=5	—	52409.0255 Hours*microgram per milliliter Standard Deviation 11814.13244
Part D: AUC0-t of TSR-042 Cycle 5, n=5	—	119847.0999 Hours*microgram per milliliter Standard Deviation 27279.85524
Part D: AUC0-t of TSR-042 Cycle 11, n=4	—	77794.6422 Hours*microgram per milliliter Standard Deviation 38680.64753

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: AUC0-t of TSR-042	—	NA Hours*microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate AUC0-t.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: AUC0-t of TSR-042	—	NA Hours*microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate AUC0-t.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: AUC0-t of TSR-022	—	NA Hours*microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate AUC0-t.

SECONDARY outcome

Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: AUC(0-infinity) of TSR-042	—	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: AUC(0-infinity) of Niraparib	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: AUC(0-infinity) of TSR-042	—	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: AUC(0-infinity) of TSR-042	—	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: AUC(0-infinity) of TSR-042	—	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: AUC(0-infinity) of TSR-022	—	NA Hours*microgram per milliliter Geometric Coefficient of Variation NA Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).

SECONDARY outcome

Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=15 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib	0.342333 Microgram per milliliter Standard Deviation 0.3301392	0.191953 Microgram per milliliter Standard Deviation 0.1309536

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=9 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Ctau of TSR-042	29.8000 Microgram per milliliter Standard Deviation 10.32570	33.6000 Microgram per milliliter Standard Deviation 12.25194

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=9 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Ctau of TSR-042	—	33.9778 Microgram per milliliter Standard Deviation 9.89846

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Ctau of Niraparib	0.478714 Microgram per milliliter Standard Deviation 0.4197538	0.161233 Microgram per milliliter Standard Deviation 0.1072328

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Ctau of TSR-042	28.7500 Microgram per milliliter Standard Deviation 9.47505	37.2750 Microgram per milliliter Standard Deviation 16.78102

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Ctau of TSR-042	—	36.5250 Microgram per milliliter Standard Deviation 12.29834

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Ctau of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Ctau.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Ctau of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Ctau.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Ctau of TSR-022	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Ctau.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=15 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Maximum Observed Plasma (Cmax) of Niraparib	0.625667 Microgram per milliliter Standard Deviation 0.4547692	0.460600 Microgram per milliliter Standard Deviation 0.2401100

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Cmax of TSR-042	138.9167 Microgram per milliliter Standard Deviation 37.87930	158.6875 Microgram per milliliter Standard Deviation 27.70251

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Cmax of TSR-042	—	148.2000 Microgram per milliliter Standard Deviation 31.27948

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Cmax of Niraparib	0.891571 Microgram per milliliter Standard Deviation 0.4638897	0.243667 Microgram per milliliter Standard Deviation 0.0889936

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Cmax of TSR-042	158.4857 Microgram per milliliter Standard Deviation 48.36788	138.6667 Microgram per milliliter Standard Deviation 24.14677

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Cmax of TSR-042	—	188.5000 Microgram per milliliter Standard Deviation 36.04858

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Cmax of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Cmax.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Cmax of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Cmax.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Cmax of TSR-022	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Cmax.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Clearance After Oral Administration (CL/F) of Niraparib Cycle 1, n=1,0	—	28.5638 Liter per hour Standard Deviation NA Standard deviation could not be calculated for single participant.
Part A: Clearance After Oral Administration (CL/F) of Niraparib Cycle 2, n=8,2	10.2833 Liter per hour Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	16.6295 Liter per hour Standard Deviation 8.70836

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Clearance After Intravenous Administration (CL) of TSR-042 Cycle 4, n=7,2	0.0110 Liter per hour Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	0.0090 Liter per hour Standard Deviation 0.00220
Part A: Clearance After Intravenous Administration (CL) of TSR-042 Cycle 5, n=8,1	0.0071 Liter per hour Standard Deviation NA Standard deviation could not be calculated for single participant.	0.0081 Liter per hour Standard Deviation 0.00238
Part A: Clearance After Intravenous Administration (CL) of TSR-042 Cycle 11, n=4,0	—	0.0072 Liter per hour Standard Deviation 0.00217

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: CL of TSR-042 Cycle 4, n=10	—	0.0098 Liter per hour Standard Deviation 0.00292
Part B: CL of TSR-042 Cycle 5, n=8	—	0.0082 Liter per hour Standard Deviation 0.00242
Part B: CL of TSR-042 Cycle 11, n=6	—	0.0092 Liter per hour Standard Deviation 0.00296

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: CL/F of Niraparib Cycle 2, n=2,4	14.4947 Liter per hour Standard Deviation 8.40967	10.3777 Liter per hour Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: CL of TSR-042 Cycle 4, n=5,5	0.0104 Liter per hour Standard Deviation 0.00268	0.0100 Liter per hour Standard Deviation 0.00441
Part C: CL of TSR-042 Cycle 5, n=5,6	0.0082 Liter per hour Standard Deviation 0.00273	0.0082 Liter per hour Standard Deviation 0.00370
Part C: CL of TSR-042 Cycle 11, n=4,2	0.0086 Liter per hour Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	0.0079 Liter per hour Standard Deviation 0.00391

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: CL of TSR-042 Cycle 4, n=5	—	0.0102 Liter per hour Standard Deviation 0.00210
Part D: CL of TSR-042 Cycle 5, n=5	—	0.0087 Liter per hour Standard Deviation 0.00169
Part D: CL of TSR-042 Cycle 11, n=3	—	0.0104 Liter per hour Standard Deviation 0.00100

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: CL of TSR-042	—	NA Liter per hour Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate CL.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: CL of TSR-042	—	NA Liter per hour Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate CL.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: CL of TSR-022	—	NA Liter per hour Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate CL.

SECONDARY outcome

Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib Cycle 1, n=1,0	—	380.1478 Liter Standard Deviation NA Standard deviation could not be calculated for single participant.
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib Cycle 2, n=8,2	487.8826 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	716.1418 Liter Standard Deviation 554.80278

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042 Cycle 4, n=5,2	10.3984 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	5.6925 Liter Standard Deviation 1.46062
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042 Cycle 5, n=8,1	6.3070 Liter Standard Deviation NA Standard deviation could not be calculated for single participant.	6.8811 Liter Standard Deviation 1.70545
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042 Cycle 11, n=4,0	—	7.4795 Liter Standard Deviation 0.90952

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Vz of TSR-042 Cycle 4, n=10	—	5.3661 Liter Standard Deviation 2.01321
Part B: Vz of TSR-042 Cycle 5, n=8	—	7.2627 Liter Standard Deviation 2.43311
Part B: Vz of TSR-042 Cycle 11, n=6	—	8.0529 Liter Standard Deviation 3.64454

SECONDARY outcome

Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Vz/F of Niraparib Cycle 2, n=2,2	559.3634 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	551.4003 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Vz of TSR-042 Cycle 4, n=5,5	5.8922 Liter Standard Deviation 2.93257	6.6462 Liter Standard Deviation 2.66825
Part C: Vz of TSR-042 Cycle 5, n=4,6	5.2066 Liter Standard Deviation 1.07206	6.1698 Liter Standard Deviation 1.73272
Part C: Vz of TSR-042 Cycle 11, n=4,2	8.5098 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	9.6347 Liter Standard Deviation 4.05466

SECONDARY outcome

Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Vz of TSR-042 Cycle 4, n=5	—	5.4955 Liter Standard Deviation 1.89543
Part D: Vz of TSR-042 Cycle 5, n=5	—	6.1542 Liter Standard Deviation 1.57345
Part D: Vz of TSR-042 Cycle 11, n=3	—	9.8356 Liter Standard Deviation 0.99107

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Vz of TSR-042	—	NA Liter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Vz.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Vz of TSR-042	—	NA Liter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Vz.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Vz of TSR-022	—	NA Liter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Vz.

SECONDARY outcome

Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: AUC at Steady State (AUCss) of Niraparib	29.4312 Hours*microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	16.3481 Hours*microgram per milliliter Standard Deviation 10.63803

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=3 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: AUCss of TSR-042 Cycle 4, n=7,2	46122.3924 Hours*microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	58598.5076 Hours*microgram per milliliter Standard Deviation 15328.61731
Part A: AUCss of TSR-042 Cycle 5, n=8,1	141306.3782 Hours*microgram per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	135171.2753 Hours*microgram per milliliter Standard Deviation 43806.32512
Part A: AUCss of TSR-042 Cycle 11, n=4,0	—	151575.3645 Hours*microgram per milliliter Standard Deviation 55194.65972

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: AUCss of TSR-042 Cycle 4, n=10	—	55073.0926 Hours*microgram per milliliter Standard Deviation 15304.21896
Part B: AUCss of TSR-042 Cycle 5, n=8	—	130694.9752 Hours*microgram per milliliter Standard Deviation 33923.75772
Part B: AUCss of TSR-042 Cycle 11, n=6	—	117033.3612 Hours*microgram per milliliter Standard Deviation 33727.51653

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: AUCss of Niraparib	26.5006 Hours*microgram per milliliter Standard Deviation 14.61077	21.4926 Hours*microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: AUCss of TSR-042 Cycle 4, n=5,5	50924.1510 Hours*microgram per milliliter Standard Deviation 13339.28085	55974.4268 Hours*microgram per milliliter Standard Deviation 16738.05254
Part C: AUCss of TSR-042 Cycle 5, n=5,6	131288.0291 Hours*microgram per milliliter Standard Deviation 36816.18787	137399.5881 Hours*microgram per milliliter Standard Deviation 45511.62023
Part C: AUCss of TSR-042 Cycle 11, n=4,2	119189.5905 Hours*microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	147907.5379 Hours*microgram per milliliter Standard Deviation 60795.87607

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: AUCss of TSR-042 Cycle 4, n=5	—	51140.4410 Hours*microgram per milliliter Standard Deviation 12597.07380
Part D: AUCss of TSR-042 Cycle 5, n=5	—	118845.3928 Hours*microgram per milliliter Standard Deviation 27874.98871
Part D: AUCss of TSR-042 Cycle 11, n=3	—	96800.1534 Hours*microgram per milliliter Standard Deviation 8871.32089

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: AUCss of TSR-042	—	NA Hours*microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate AUCss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: AUCss of TSR-042	—	NA Hours*microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate AUCss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: AUCss of TSR-022	—	NA Hours*microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate AUCss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=11 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Ctau at Steady State (Ctau,ss) of Niraparib Cycle 2, n=11,6	0.622000 Microgram per milliliter Standard Deviation 0.4523848	0.507900 Microgram per milliliter Standard Deviation 0.3937657

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Ctau,ss of TSR-042 Cycle 4, n=8,1	63.3000 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	77.3625 Microgram per milliliter Standard Deviation 28.55145
Part A: Ctau,ss of TSR-042 Cycle 5, n=8,1	71.2000 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	68.5500 Microgram per milliliter Standard Deviation 34.63879
Part A: Ctau,ss of TSR-042 Cycle 11, n=4,0	—	93.8000 Microgram per milliliter Standard Deviation 47.28939

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=9 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Ctau,ss of TSR-042 Cycle 4, n=9	—	67.2444 Microgram per milliliter Standard Deviation 24.15130
Part B: Ctau,ss of TSR-042 Cycle 5, n=8	—	59.3000 Microgram per milliliter Standard Deviation 16.75913
Part B: Ctau,ss of TSR-042 Cycle 11, n=6	—	57.4833 Microgram per milliliter Standard Deviation 20.98136

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Ctau,ss of Niraparib Cycle 2, n=5,4	1.094250 Microgram per milliliter Standard Deviation 0.7660576	0.484000 Microgram per milliliter Standard Deviation 0.3511339

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Ctau,ss of TSR-042 Cycle 4, n=4,6	64.2667 Microgram per milliliter Standard Deviation 23.55315	70.4250 Microgram per milliliter Standard Deviation 34.00896
Part C: Ctau,ss of TSR-042 Cycle 5, n=5,6	53.1500 Microgram per milliliter Standard Deviation 24.80538	82.9800 Microgram per milliliter Standard Deviation 43.98252
Part C: Ctau,ss of TSR-042 Cycle 11, n=3,2	60.9500 Microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	105.4667 Microgram per milliliter Standard Deviation 22.28909

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Ctau,ss of TSR-042 Cycle 4, n=5	—	53.5200 Microgram per milliliter Standard Deviation 13.87271
Part D: Ctau,ss of TSR-042 Cycle 5, n=5	—	48.0800 Microgram per milliliter Standard Deviation 23.95343
Part D: Ctau,ss of TSR-042 Cycle 11, n=3	—	43.3000 Microgram per milliliter Standard Deviation 4.80729

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Ctau,ss of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Ctau,ss of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Ctau,ss of TSR-022	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=3 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Cmax at Steady State (Cmax,ss) of Niraparib Cycle 2, n=10,3	1.706667 Microgram per milliliter Standard Deviation 0.0838650	0.925900 Microgram per milliliter Standard Deviation 0.6661597
Part A: Cmax at Steady State (Cmax,ss) of Niraparib Cycle 5, n=7,0	—	0.839071 Microgram per milliliter Standard Deviation 0.6183628
Part A: Cmax at Steady State (Cmax,ss) of Niraparib Cycle 11, n=2,0	—	0.768000 Microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=9 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Cmax,ss of TSR-042 Cycle 4, n=9,4	178.5000 Microgram per milliliter Standard Deviation 26.18524	222.5556 Microgram per milliliter Standard Deviation 51.37633
Part A: Cmax,ss of TSR-042 Cycle 5, n=8,1	319.0000 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	393.8750 Microgram per milliliter Standard Deviation 100.81729
Part A: Cmax,ss of TSR-042 Cycle 11, n=5,0	—	405.4000 Microgram per milliliter Standard Deviation 103.69812

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Cmax,ss of TSR-042 Cycle 4, n=10	—	225.8000 Microgram per milliliter Standard Deviation 51.71460
Part B: Cmax,ss of TSR-042 Cycle 5, n=9	—	421.1111 Microgram per milliliter Standard Deviation 114.84603
Part B: Cmax,ss of TSR-042 Cycle 11, n=6	—	446.6667 Microgram per milliliter Standard Deviation 160.53868

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Cmax,ss of Niraparib Cycle 2, n=4,4	1.404750 Microgram per milliliter Standard Deviation 0.6642366	0.854500 Microgram per milliliter Standard Deviation 0.3934637
Part C: Cmax,ss of Niraparib Cycle 5, n=4,3	1.073667 Microgram per milliliter Standard Deviation 0.5474124	0.709750 Microgram per milliliter Standard Deviation 0.2693788
Part C: Cmax,ss of Niraparib Cycle 11, n=3,1	0.638000 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	0.468333 Microgram per milliliter Standard Deviation 0.1418955

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Cmax,ss of TSR-042 Cycle 4, n=5,7	227.1429 Microgram per milliliter Standard Deviation 42.65923	234.4000 Microgram per milliliter Standard Deviation 31.76948
Part C: Cmax,ss of TSR-042 Cycle 5, n=5,6	417.3333 Microgram per milliliter Standard Deviation 139.40397	325.2000 Microgram per milliliter Standard Deviation 73.90332
Part C: Cmax,ss of TSR-042 Cycle 11, n=4,2	321.0000 Microgram per milliliter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	349.7500 Microgram per milliliter Standard Deviation 111.53886

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Cmax,ss of TSR-042 Cycle 4, n=5	—	256.8000 Microgram per milliliter Standard Deviation 76.90709
Part D: Cmax,ss of TSR-042 Cycle 5, n=5	—	416.0000 Microgram per milliliter Standard Deviation 89.43433
Part D: Cmax,ss of TSR-042 Cycle 11, n=4	—	429.7500 Microgram per milliliter Standard Deviation 72.86231

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Cmax,ss of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Cmax,ss of TSR-042	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Cmax,ss of TSR-022	—	NA Microgram per milliliter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=15 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib	4.083 Hours Interval 2.02 to 25.65	2.250 Hours Interval 1.75 to 7.02

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=16 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Tmax of TSR-042	1.750 Hours Interval 0.5 to 23.17	0.817 Hours Interval 0.5 to 2.58

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Tmax of TSR-042	—	1.000 Hours Interval 0.55 to 27.28

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Tmax of Niraparib	4.050 Hours Interval 2.05 to 22.6	3.975 Hours Interval 2.0 to 23.33

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Tmax of TSR-042	0.583 Hours Interval 0.5 to 2.35	1.200 Hours Interval 0.5 to 4.48

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Tmax of TSR-042	—	1.250 Hours Interval 0.5 to 25.17

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Tmax of TSR-042	—	NA Hours Data was not collected due to insufficient number of participants with data to calculate Tmax.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Tmax of TSR-042	—	NA Hours Data was not collected due to insufficient number of participants with data to calculate Tmax.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Tmax of TSR-022	—	NA Hours Data was not collected due to insufficient number of participants with data to calculate Tmax.

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=3 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Tmax at Steady State (Tmax,ss) of Niraparib Cycle 2, n=10,3	2.250 Hours Interval 2.08 to 7.0	4.008 Hours Interval 1.0 to 22.68
Part A: Tmax at Steady State (Tmax,ss) of Niraparib Cycle 5, n=7,0	—	2.000 Hours Interval 0.0 to 2.0
Part A: Tmax at Steady State (Tmax,ss) of Niraparib Cycle 11, n=2,0	—	1.817 Hours Interval 1.75 to 1.88

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=9 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Tmax,ss of TSR-042 Cycle 4, n=9,4	1.300 Hours Interval 0.5 to 2.7	1.500 Hours Interval 0.5 to 2.07
Part A: Tmax,ss of TSR-042 Cycle 5, n=8,1	2.783 Hours Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.	0.625 Hours Interval 0.5 to 1.73
Part A: Tmax,ss of TSR-042 Cycle 11, n=5,0	—	0.567 Hours Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Tmax,ss of TSR-042 Cycle 4, n=10	—	0.575 Hours Interval 0.5 to 2.08
Part B: Tmax,ss of TSR-042 Cycle 5, n=9	—	1.500 Hours Interval 0.5 to 2.1
Part B: Tmax,ss of TSR-042 Cycle 11, n=6	—	0.542 Hours Interval 0.42 to 2.07

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=4 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Tmax,ss of Niraparib Cycle 2, n=4,4	3.958 Hours Interval 2.0 to 6.0	4.950 Hours Interval 2.03 to 22.3
Part C: Tmax,ss of Niraparib Cycle 5, n=4,3	1.967 Hours Interval 1.17 to 2.0	2.158 Hours Interval 1.82 to 2.68
Part C: Tmax,ss of Niraparib Cycle 11, n=3,1	2.083 Hours Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.	2.000 Hours Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Tmax,ss of TSR-042 Cycle 4, n=5,7	0.617 Hours Interval 0.5 to 2.0	1.517 Hours Interval 0.5 to 20.67
Part C: Tmax,ss of TSR-042 Cycle 5, n=5,6	0.825 Hours Interval 0.5 to 2.25	2.083 Hours Interval 0.5 to 2.58
Part C: Tmax,ss of TSR-042 Cycle 11, n=4,2	2.417 Hours Interval 2.17 to 2.67	2.000 Hours Interval 1.98 to 2.0

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Tmax,ss of TSR-042 Cycle 4, n=5	—	0.500 Hours Interval 0.5 to 2.0
Part D: Tmax,ss of TSR-042 Cycle 5, n=5	—	0.550 Hours Interval 0.5 to 2.0
Part D: Tmax,ss of TSR-042 Cycle 11, n=4	—	0.500 Hours Interval 0.5 to 0.5

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Tmax,ss of TSR-042	—	NA Hours Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Tmax,ss of TSR-042	—	NA Hours Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Tmax,ss of TSR-022	—	NA Hours Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=8 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042 Cycle 4, n=5,2	9.8680 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	5.5647 Liter Standard Deviation 1.36694
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042 Cycle 5, n=8,1	5.9659 Liter Standard Deviation NA Standard deviation could not be calculated for single participant.	6.6580 Liter Standard Deviation 1.53521
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042 Cycle 11, n=4,0	—	7.3107 Liter Standard Deviation 0.96007

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=10 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part B: Vss of TSR-042 Cycle 4, n=10	—	5.1893 Liter Standard Deviation 1.80311
Part B: Vss of TSR-042 Cycle 5, n=8	—	6.7701 Liter Standard Deviation 2.31992
Part B: Vss of TSR-042 Cycle 11, n=6	—	7.4351 Liter Standard Deviation 2.78481

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=6 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part C: Vss of TSR-042 Cycle 4, n=5,5	5.5177 Liter Standard Deviation 2.39652	6.4567 Liter Standard Deviation 2.68944
Part C: Vss of TSR-042 Cycle 5, n=4,6	4.8035 Liter Standard Deviation 0.72905	6.2405 Liter Standard Deviation 1.79539
Part C: Vss of TSR-042 Cycle 11, n=4,2	7.7750 Liter Standard Deviation NA Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	8.9478 Liter Standard Deviation 3.05769

SECONDARY outcome

Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=5 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part D: Vss of TSR-042 Cycle 4, n=5	—	5.1493 Liter Standard Deviation 1.58340
Part D: Vss of TSR-042 Cycle 5, n=5	—	5.6399 Liter Standard Deviation 1.41478
Part D: Vss of TSR-042 Cycle 11, n=3	—	8.0614 Liter Standard Deviation 0.48037

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=2 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part E: Vss of TSR-042	—	NA Liter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Vss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Vss of TSR-042	—	NA Liter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Vss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Outcome measures

Measure	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=1 Participants Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Part F: Vss of TSR-022	—	NA Liter Standard Deviation NA Data was not collected due to insufficient number of participants with data to calculate Vss.

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Blood samples were planned to be collected at indicated time points.

Outcome measures

Outcome data not reported

Adverse Events

Main Study: Part A: TSR-042 and Niraparib 200 mg QD

Serious events: 11 serious events

Other events: 16 other events

Deaths: 4 deaths

Main Study: Part A: TSR-042 and Niraparib 300 mg QD

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Main Study: Part B: TSR-042 and Carboplatin-paclitaxel

Serious events: 9 serious events

Other events: 14 other events

Deaths: 7 deaths

Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 5 deaths

Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Main Study: Part E: TSR-042 and Carboplatin-pemetrexed

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Main Study: Part A: TSR-042 and Niraparib 200 mg QD n=16 participants at risk Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.	Main Study: Part A: TSR-042 and Niraparib 300 mg QD n=6 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab n=6 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab n=6 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part E: TSR-042 and Carboplatin-pemetrexed n=2 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).	Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed n=1 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).	PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel n=2 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab n=1 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Neutropenia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Atrial fibrillation	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Atrioventricular block complete	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Ileus	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Intestinal obstruction	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Asthenia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Fatigue	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Mucosal inflammation	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Non-cardiac chest pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Sudden death	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Hepatobiliary disorders Hepatitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Appendicitis perforated	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Gastroenteritis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Pneumonia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Sinusitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Staphylococcal abscess	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Procedural pain	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Hydronephrosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hypercalcaemia	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Haemorrhage intracranial	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Vertebral artery dissection	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Urinary retention	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders General Medical Deterioration	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.

Other adverse events

Measure	Main Study: Part A: TSR-042 and Niraparib 200 mg QD n=16 participants at risk Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.	Main Study: Part A: TSR-042 and Niraparib 300 mg QD n=6 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel n=14 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab n=6 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab n=7 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab n=6 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	Main Study: Part E: TSR-042 and Carboplatin-pemetrexed n=2 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).	Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed n=1 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).	PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel n=2 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab n=1 participants at risk Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
General disorders Swelling face	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Anaemia	25.0% 4/16 • Number of events 13 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	71.4% 10/14 • Number of events 27 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	71.4% 5/7 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	83.3% 5/6 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 2/2 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 12 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Haemolysis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Lymphadenopathy	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Atrial fibrillation	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Neutropenia	6.2% 1/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	42.9% 6/14 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 15 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 4/16 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 19 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Palpitations	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Sinus tachycardia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Cardiac disorders Tachycardia	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Ear and labyrinth disorders Deafness	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Ear and labyrinth disorders Ear discomfort	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Ear and labyrinth disorders Ear pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Ear and labyrinth disorders Vertigo	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Endocrine disorders Hyperthyroidism	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Endocrine disorders Hypothyroidism	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Blepharitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Dacryostenosis acquired	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Diplopia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Eye haemorrhage	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Ocular hyperaemia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Ophthalmoplegia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Vision blurred	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Eye disorders Visual impairment	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Abdominal discomfort	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Abdominal distension	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Abdominal pain	25.0% 4/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Anal fistula	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Ascites	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Colitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Constipation	31.2% 5/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 2/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Dental caries	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	42.9% 6/14 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 21 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Dry mouth	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Dyspepsia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Dysphagia	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Faeces hard	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Flatulence	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Gastric disorder	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Haematochezia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Haemorrhoids	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Hiatus hernia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Hypertrophy of tongue papillae	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Inguinal hernia	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Nausea	50.0% 8/16 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 4/7 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 2/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Oesophagitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Oral discomfort	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Oral pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Peptic ulcer	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Stomatitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Tooth loss	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Gastrointestinal disorders Vomiting	31.2% 5/16 • Number of events 11 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Asthenia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Chest discomfort	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Chest pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Chills	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Cyst rupture	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Fatigue	25.0% 4/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 7/14 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Gait disturbance	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Localised oedema	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Malaise	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Mucosal inflammation	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Non-cardiac chest pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Oedema peripheral	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Pain	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Peripheral swelling	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Pyrexia	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Swelling	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
General disorders Temperature intolerance	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Immune system disorders Seasonal allergy	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Acute sinusitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Bacterial vaginosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Bacterial vulvovaginitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Candida infection	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Cellulitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Conjunctivitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Cystitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Dacryocystitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Folliculitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Gastroenteritis viral	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Herpes zoster	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Influenza	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Kidney infection	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Lung abscess	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Nasopharyngitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Onychomycosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Oral candidiasis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Pneumonia	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Sepsis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Sinusitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Stoma site infection	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Upper respiratory tract infection	18.8% 3/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Urinary tract infection	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Viral pharyngitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Contusion	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Fall	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Radiation injury	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Recall phenomenon	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Activated partial thromboplastin time prolonged	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Alanine aminotransferase increased	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Amylase increased	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Aspartate aminotransferase increased	18.8% 3/16 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood alkaline phosphatase increased	12.5% 2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood bilirubin increased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood creatinine increased	12.5% 2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood folate decreased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood potassium decreased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood pressure increased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood testosterone decreased	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood thyroid stimulating hormone increased	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Blood uric acid increased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Breath sounds abnormal	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Cardiac murmur	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations International normalised ratio increased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Lymphocyte count decreased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Neutrophil count decreased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Platelet count decreased	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Tri-iodothyronine decreased	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Vitamin B12 decreased	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Weight decreased	25.0% 4/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations Weight increased	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Investigations White blood cell count decreased	12.5% 2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Decreased appetite	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	35.7% 5/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	42.9% 3/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Dehydration	25.0% 4/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 2/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Fluid retention	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hypercalcaemia	6.2% 1/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hyperphosphataemia	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Balance disorder	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hypokalaemia	31.2% 5/16 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	35.7% 5/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hypomagnesaemia	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Hyponatraemia	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Metabolism and nutrition disorders Malnutrition	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	42.9% 6/14 • Number of events 11 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Back pain	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Bone pain	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Flank pain	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Muscle spasms	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Soft tissue mass	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Autonomic neuropathy	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Disturbance in attention	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Dizziness	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Dizziness postural	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Dysgeusia	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Encephalopathy	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Headache	18.8% 3/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Hemiparesis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Hyperreflexia	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Memory impairment	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Neuralgia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Neuropathy peripheral	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Paraesthesia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Peripheral sensory neuropathy	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Post herpetic neuralgia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Sciatica	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Somnolence	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Spinal cord compression	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Syncope	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Nervous system disorders Tremor	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Product Issues Device malfunction	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Product Issues Device occlusion	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Anxiety	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Confusional state	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Depression	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Disorientation	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Hallucination, visual	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Insomnia	18.8% 3/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Mental status changes	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Psychiatric disorders Sleep disorder	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Chronic kidney disease	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Dysuria	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Haematuria	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Incontinence	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Leukocyturia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Nocturia	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Renal and urinary disorders Proteinuria	6.2% 1/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 4/7 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Rash	25.0% 4/16 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Reproductive system and breast disorders Pruritus genital	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 4/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	21.4% 3/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 4/16 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	42.9% 6/14 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	57.1% 8/14 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	83.3% 5/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Rash macular	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Deep vein thrombosis	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Hot flush	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Hypertension	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	66.7% 4/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 3/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Hypotension	12.5% 2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Orthostatic hypotension	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Pallor	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
Vascular disorders Venous thrombosis limb	0.00% 0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.	0.00% 0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase. Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.

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