Trial Outcomes & Findings for Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants (NCT NCT03308942)

Last Updated: 2023-10-16

Results Overview

ORR is the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in the analysis population 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. Tumor assessment was done by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Data has been presented for participants with NSCLC whose tumors have high PD-L1 expression (TPS\>=50%). Confidence interval was calculated using binomial exact method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Up to a maximum of 29 months

Results posted on

2023-10-16

Participant Flow

This study consisted of two stages; Stage 1 (Cohorts 1, 2, 3) and Stage 2 (Cohorts 1A, 2A).

A total of 69 participants were screened, of which 16 failed screening and 53 participants (41 in Stage 1 and 12 in Stage 2) were enrolled into the study. Data was not collected for Cohort 2A of Stage 2 as the Sponsor decided not to open this Cohort to enrollment.

Participant milestones

Participant milestones
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 1 (Cohort 2): Niraparib + Pembrolizumab Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.	Stage 1 (Cohort 3): Niraparib Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.	Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: \>= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).
Stage 1 (Up to a Maximum of 45 Months) STARTED	17	21	3	0
Stage 1 (Up to a Maximum of 45 Months) COMPLETED	0	0	0	0
Stage 1 (Up to a Maximum of 45 Months) NOT COMPLETED	17	21	3	0
Stage 2 (Up to a Maximum of 29 Months) STARTED	0	0	0	12
Stage 2 (Up to a Maximum of 29 Months) COMPLETED	0	0	0	0
Stage 2 (Up to a Maximum of 29 Months) NOT COMPLETED	0	0	0	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 1 (Cohort 2): Niraparib + Pembrolizumab Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.	Stage 1 (Cohort 3): Niraparib Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.	Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: \>= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).
Stage 1 (Up to a Maximum of 45 Months) Withdrawal by Subject	3	3	2	0
Stage 1 (Up to a Maximum of 45 Months) Death	11	16	1	0
Stage 1 (Up to a Maximum of 45 Months) Lost to Follow-up	0	1	0	0
Stage 1 (Up to a Maximum of 45 Months) Sponsor Decision	3	1	0	0
Stage 2 (Up to a Maximum of 29 Months) Withdrawal by Subject	0	0	0	3
Stage 2 (Up to a Maximum of 29 Months) Death	0	0	0	6
Stage 2 (Up to a Maximum of 29 Months) Sponsor Decision	0	0	0	3

Baseline Characteristics

Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=17 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 1 (Cohort 2): Niraparib + Pembrolizumab n=21 Participants Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.	Stage 1 (Cohort 3): Niraparib n=3 Participants Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.	Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) n=12 Participants Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: \>= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planned to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).	Total n=53 Participants Total of all reporting groups
Age, Continuous	70.1 Years STANDARD_DEVIATION 7.55 • n=99 Participants	70.9 Years STANDARD_DEVIATION 9.78 • n=107 Participants	72.3 Years STANDARD_DEVIATION 10.69 • n=206 Participants	68.3 Years STANDARD_DEVIATION 6.74 • n=7 Participants	—	70.1 Years STANDARD_DEVIATION 8.35 • n=30 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	12 Participants n=107 Participants	0 Participants n=206 Participants	6 Participants n=7 Participants	—	24 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	9 Participants n=107 Participants	3 Participants n=206 Participants	6 Participants n=7 Participants	—	29 Participants n=30 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	—	1 Participants n=30 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	—	2 Participants n=30 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	—	3 Participants n=30 Participants
Race/Ethnicity, Customized White	14 Participants n=99 Participants	19 Participants n=107 Participants	3 Participants n=206 Participants	8 Participants n=7 Participants	—	44 Participants n=30 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	—	3 Participants n=30 Participants

PRIMARY outcome

Timeframe: Up to a maximum of 29 months

Population: Modified intent-to-treat (mITT) Population comprised of all participants who received any study drug and did not withdraw consent prior to having at least one post-Baseline tumor assessment.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=16 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 1: Objective Response Rate (ORR)	56.3 Percentage of participants Interval 29.9 to 80.2	—

PRIMARY outcome

Timeframe: Up to a maximum of 17 months

Population: mITT Population

ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population 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. Tumor assessment was done by the Investigator per RECIST v1.1. Data has been presented for participants with NSCLC having PD-L1 expression in tumors (TPS: 1 to 49%). Confidence interval was calculated using binomial exact method.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=20 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 2: Objective Response Rate	20.0 Percentage of participants Interval 5.7 to 43.7	—

PRIMARY outcome

Timeframe: Up to a maximum of 6 months

Population: mITT Population

ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population 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. Tumor assessment was done by the Investigator per RECIST v1.1. Data is presented for participants with locally advanced and metastatic squamous NSCLC. Confidence interval was calculated using binomial exact method.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=2 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 3: Objective Response Rate	0 Percentage of participants Interval 0.0 to 84.2	—

PRIMARY outcome

Timeframe: Up to a maximum of 17 months

Population: mITT Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study.

ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population 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. Tumor assessment was done by the Investigator per RECIST v1.1. Confidence interval was calculated using binomial exact method.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=11 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohort 1A and Cohort 2A: Objective Response Rate	9.1 Percentage of participants Interval 0.2 to 41.3	—

SECONDARY outcome

Timeframe: Up to a maximum of 45 months

Population: Safety Population comprised of participants who received at least one dose of either study medications.

An adverse event (AE) is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=17 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 1: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Any SAE	11 Participants	—
Stage 1: Cohort 1: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Any non-SAE	17 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 17 months

Population: Safety Population

An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=21 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 2: Number of Participants With Non-SAEs and SAEs Any SAE	14 Participants	—
Stage 1: Cohort 2: Number of Participants With Non-SAEs and SAEs Any non-SAE	20 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 6 months

Population: Safety Population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=3 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 3: Number of Participants With Non-SAEs and SAEs Any SAE	1 Participants	—
Stage 1: Cohort 3: Number of Participants With Non-SAEs and SAEs Any non-SAE	3 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 29 months

Population: Safety Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=12 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohorts 1A and 2A: Number of Participants With Non-SAEs and SAEs Any SAE	7 Participants	—
Stage 2: Cohorts 1A and 2A: Number of Participants With Non-SAEs and SAEs Any non-SAE	12 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 45 months

Population: Safety population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=17 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 1: Number of Participants Discontinuing the Study Due to AEs	10 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 17 months

Population: Safety population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=21 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 2: Number of Participants Discontinuing the Study Due to AEs	9 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 6 months

Population: Safety Population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=3 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 3: Number of Participants Discontinuing the Study Due to AEs	1 Participants	—

SECONDARY outcome

Timeframe: Up to maximum 29 months

Population: Safety Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=12 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohorts 1A and 2A: Number of Participants Discontinuing the Study Due to AEs	2 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 45 months

Population: mITT Population. Only those participants with confirmed response were analyzed.

Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (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 measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=9 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 1: Duration of Response	22.8 Months Interval 10.1 to NA indicates \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	—

SECONDARY outcome

Timeframe: Up to a maximum of 17 months

Population: mITT Population. Only those participants with confirmed response were analyzed.

Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; 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 measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=4 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 2: Duration of Response	9.4 Months Interval 5.2 to 13.8	—

SECONDARY outcome

Timeframe: Up to a maximum of 6 months

Population: mITT Population. No participant had confirmed response. Hence, data for duration of response was not collected.

Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; 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 a maximum of 29 months

Population: mITT Population. Only those participants with confirmed response were analyzed. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study.

Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; 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 measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=1 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohorts 1A and 2A: Duration of Response	21.5 Months NA indicates, as there was a single participant, median value presented is the actual value. Hence, inter quartile range could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Up to a maximum of 45 months

Population: mITT Population

Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; 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. Confidence interval was calculated using binomial exact method.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=16 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1 : Cohort 1: Disease Control Rate	87.5 Percentage of participants Interval 61.7 to 98.4	—

SECONDARY outcome

Timeframe: Up to a maximum of 17 months

Population: mITT Population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=20 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1 : Cohort 2: Disease Control Rate	70.0 Percentage of participants Interval 45.7 to 88.1	—

SECONDARY outcome

Timeframe: Up to a maximum of 6 months

Population: mITT Population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=2 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1 : Cohort 3: Disease Control Rate	50.0 Percentage of participants Interval 1.3 to 98.7	—

SECONDARY outcome

Timeframe: Up to a maximum of 29 months

Population: mITT Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=11 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohorts 1A and 2A: Disease Control Rate	54.5 Percentage of participants Interval 23.4 to 83.3	—

SECONDARY outcome

Timeframe: Up to a maximum of 45 months

Population: mITT Population

Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=16 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1 : Cohort 1: Progression-free Survival	8.4 Months Interval 3.9 to 36.2	—

SECONDARY outcome

Timeframe: Up to a maximum of 17 months

Population: mITT Population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=20 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1 : Cohort 2: Progression-free Survival	4.2 Months Interval 2.0 to 6.2	—

SECONDARY outcome

Timeframe: Up to a maximum of 6 months

Population: mITT Population

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=2 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1 : Cohort 3: Progression-free Survival	4.0 Months Interval 1.3 to 6.6	—

SECONDARY outcome

Timeframe: Up to a maximum of 29 months

Population: mITT Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=11 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohorts 1A and 2A: Progression-free Survival	4.4 Months Interval 2.0 to NA indicates that \<55% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1(Pre-dose and 30 Minutes, 1 Hour, 2 Hours, 4 Hours, 8 Hours, 96 Hours, 168 Hours Post-dose); Cycles 2, 4, 8 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days)

Population: Pharmacokinetic Population comprised of participants who had at least one of measurable niraparib concentration. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=17 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; Pre-dose	28.4 Nanograms per milliliter Standard Deviation 115	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 30 Minutes Post-dose	201 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 1 Hour Post-dose	500 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 2 Hours Post-dose	733 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 4 Hours Post-dose	335 Nanograms per milliliter Standard Deviation 233	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 8 Hours Post-dose	353 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 96 Hours Post-dose	1400 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 168 Hours Post-dose	1440 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 2; Pre-dose	360 Nanograms per milliliter Standard Deviation 383	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 2; 4 Hours Post-dose	959 Nanograms per milliliter Standard Deviation 506	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; Pre-dose	600 Nanograms per milliliter Standard Deviation 505	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 4 Hours Post-dose	794 Nanograms per milliliter Standard Deviation 597	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 8; Pre-dose	460 Nanograms per milliliter Standard Deviation 543	—
Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 8; 4 Hours Post-dose	727 Nanograms per milliliter Standard Deviation 824	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Pre-dose and 30 Minutes, 1, 2, 4, 8, 24, 168, 336 Hours Post-dose), Cycles 2, 8 (Pre-dose and 4 Hours Post-dose), Cycle 4 (Pre-dose and 30 Minutes, 1, 2, 4, 8, 24, 96, 168, 336 Hours Post-dose) (each cycle of 21 days)

Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=21 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; Pre-dose	NA Nanograms per milliliter Standard Deviation NA NA indicates that data was not available as no concentration values were detected for pre-dose.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 30 Minutes Post-dose	24.5 Nanograms per milliliter Standard Deviation 42.4	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 1 Hour Post-dose	189 Nanograms per milliliter Standard Deviation 302	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 2 Hours Post-dose	264 Nanograms per milliliter Standard Deviation 251	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 4 Hours Post-dose	345 Nanograms per milliliter Standard Deviation 188	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 8 Hours Post-dose	238 Nanograms per milliliter Standard Deviation NA NA indicates that standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 24 Hours Post-dose	318 Nanograms per milliliter Standard Deviation NA NA indicates that standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 168 Hours Post-dose	759 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 1 Day 1; 336 Hours Post-dose	808 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 2; Pre-dose	767 Nanograms per milliliter Standard Deviation 362	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 2; 4 Hours Post-dose	1170 Nanograms per milliliter Standard Deviation 473	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; Pre-dose	805 Nanograms per milliliter Standard Deviation 588	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 30 Minutes Post-dose	841 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 1 Hour Post-dose	1260 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 2 Hours Post-dose	1290 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 4 Hours Post-dose	1040 Nanograms per milliliter Standard Deviation 668	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 8 Hours, Post-dose	978 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 24 Hours Post-dose	660 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 96 Hours	773 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 168 Hours	767 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 4; 336 Hours	924 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 8; Pre-dose	342 Nanograms per milliliter Standard Deviation 123	—
Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab Cycle 8; 4 Hours post-dose	602 Nanograms per milliliter Standard Deviation 290	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Pre-dose and 4 Hours Post-dose), Cycles 2, 4 and 8 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days)

Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=3 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 1 Day 1; Pre-dose	NA Nanograms per milliliter Standard Deviation NA NA indicates that data was not available as no concentration values detected for pre-dose.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 1 Day 1; 4 Hours Post-dose	279 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 2; Pre-dose	469 Nanograms per milliliter Standard Deviation NA NA indicates that standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 2; 4 Hours Post-dose	717 Nanograms per milliliter Standard Deviation NA NA indicates that standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 4; Pre-dose	615 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 4; 4 Hours Post-dose	871 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 8; Pre-dose	478 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—
Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy Cycle 8; 4 Hours Post-dose	913 Nanograms per milliliter Standard Deviation NA NA indicates data was not available as standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Pre-dose and 4 Hours Post-dose), Cycles 2, 4 and 9 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days)

Population: Pharmacokinetic Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points.

Outcome measures

Outcome measures
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=12 Participants Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 2; Pre-dose	669 Nanograms per milliliter Standard Deviation 503	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 1 Day 1; Pre-dose	NA Nanograms per milliliter Standard Deviation NA NA indicates that data was not available as no concentration values detected for pre-dose.	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 1 Day 1; 4 Hours Post-dose	328 Nanograms per milliliter Standard Deviation 254	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 2; 4 Hours Post-dose	967 Nanograms per milliliter Standard Deviation 540	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 4; Pre-dose	486 Nanograms per milliliter Standard Deviation 243	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 4; 4 Hours Post-dose	795 Nanograms per milliliter Standard Deviation 228	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 9; Pre-dose	456 Nanograms per milliliter Standard Deviation 134	—
Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) Cycle 9; 4 Hours Post-dose	766 Nanograms per milliliter Standard Deviation 231	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to a maximum of 45 months

Population: mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study.

Overall survival was defined as the time from date of first dose to the date of death due to any cause.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to a maximum of 17 months

Population: mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study.

Overall survival was defined as the time from date of first dose to the date of death due to any cause.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to a maximum of 6 months

Population: mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study.

Overall survival was defined as the time from date of first dose to the date of death due to any cause.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to a maximum of 29 months

Population: mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study.

Overall survival was defined as the time from date of first dose to the date of death due to any cause.

Outcome measures

Outcome data not reported

Adverse Events

Stage 1 (Cohort 1): Niraparib + Pembrolizumab

Serious events: 11 serious events

Other events: 17 other events

Deaths: 11 deaths

Stage 1 (Cohort 2): Niraparib + Pembrolizumab

Serious events: 14 serious events

Other events: 20 other events

Deaths: 16 deaths

Stage 1 (Cohort 3): Niraparib

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)

Serious events: 7 serious events

Other events: 12 other events

Deaths: 6 deaths

Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=17 participants at risk Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 1 (Cohort 2): Niraparib + Pembrolizumab n=21 participants at risk Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.	Stage 1 (Cohort 3): Niraparib n=3 participants at risk Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.	Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) n=12 participants at risk Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: \>= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	19.0% 4/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Pneumonia	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Sepsis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Diverticulitis	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Atrial fibrillation	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Cardiac arrest	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Pericardial effusion	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Diarrhoea	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Pancreatitis acute	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Proctalgia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Blood and lymphatic system disorders Anaemia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Encephalopathy	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Facial paralysis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Ischaemic stroke	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Syncope	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Mental status changes	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Delirium	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Psychotic disorder	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Oedema peripheral	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Fall	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Failure to thrive	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Lipase increased	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Constipation	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Confusional state	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Hypotension	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Pleural infection	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Angina pectoris	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Myocardial infarction	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.

Other adverse events

Other adverse events
Measure	Stage 1 (Cohort 1): Niraparib + Pembrolizumab n=17 participants at risk Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score \[TPS\]: \>= 50 percent \[%\]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.	Stage 1 (Cohort 2): Niraparib + Pembrolizumab n=21 participants at risk Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.	Stage 1 (Cohort 3): Niraparib n=3 participants at risk Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.	Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) n=12 participants at risk Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: \>= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).	Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
Gastrointestinal disorders Nausea	41.2% 7/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	57.1% 12/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	66.7% 2/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	58.3% 7/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Constipation	41.2% 7/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	47.6% 10/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 4/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Diarrhoea	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	50.0% 6/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Vomiting	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	23.8% 5/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	25.0% 3/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Stomatitis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	23.8% 5/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Abdominal pain	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Sinusitis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Haematochezia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Haemorrhoids	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Colitis	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Dysphagia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	38.1% 8/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Cough	41.2% 7/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Chills	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	66.7% 2/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Fatigue	47.1% 8/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	42.9% 9/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	41.7% 5/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Oedema peripheral	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	23.8% 5/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	41.7% 5/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Non-cardiac chest pain	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Chest pain	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Gait disturbance	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Pain	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Pyrexia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Asthenia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Malaise	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Pneumonia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	25.0% 3/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Upper respiratory tract infection	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Urinary tract infection	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Candida infection	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Fungal infection	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Decreased appetite	41.2% 7/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	52.4% 11/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 4/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Dehydration	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hypokalaemia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hyponatraemia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Platelet count decreased	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	23.8% 5/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Weight decreased	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Blood alkaline phosphatase increased	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	19.0% 4/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Aspartate aminotransferase increased	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Blood creatinine increased	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	25.0% 3/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Neutrophil count decreased	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Alanine aminotransferase increased	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Amylase increased	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Lymphocyte count decreased	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Blood and lymphatic system disorders Anaemia	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	47.6% 10/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Blood and lymphatic system disorders Thrombocytopenia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Dizziness	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Dysgeusia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Peripheral sensory neuropathy	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Headache	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Lethargy	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Neuropathy peripheral	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Insomnia	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	19.0% 4/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Anxiety	23.5% 4/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Confusional state	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Depression	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	19.0% 4/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Back pain	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Muscular weakness	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	14.3% 3/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	25.0% 3/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Flank pain	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Pruritus	17.6% 3/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	19.0% 4/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Rash	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Atrial fibrillation	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Sinus tachycardia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Tachycardia	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Cardiac failure congestive	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Fall	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Contusion	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Overdose	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Dysuria	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Urinary incontinence	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Hypotension	11.8% 2/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Hypertension	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	25.0% 3/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Endocrine disorders Hypothyroidism	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Eye disorders Vision blurred	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	9.5% 2/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Syncope	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Pollakiuria	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	33.3% 1/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Catheter site irritation	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Catheter site pain	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
General disorders Physical deconditioning	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Clostridium difficile colitis	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Blood and lymphatic system disorders Neutropenia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	16.7% 2/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Aphasia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Restless legs syndrome	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Taste disorder	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Acute kidney injury	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Flushing	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Superior vena cava syndrome	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Ear and labyrinth disorders Vertigo positional	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	4.8% 1/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Hot flush	0.00% 0/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	8.3% 1/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Levator syndrome	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Gastrointestinal disorders Lip disorder	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Respiratory, thoracic and mediastinal disorders Tachypnoea	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Bacteraemia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Mucosal infection	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Nasopharyngitis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Oral candidiasis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Infections and infestations Viral infection	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Lactic acidosis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Metabolism and nutrition disorders Malnutrition	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Blood magnesium decreased	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Haemoglobin decreased	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Investigations Vitamin D decreased	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Blood and lymphatic system disorders Lymphadenitis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Blood and lymphatic system disorders Thrombocytosis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Amnesia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Cognitive disorder	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Dizziness postural	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Horner's syndrome	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Ischaemic stroke	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Memory impairment	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Neuralgia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Nervous system disorders Peroneal nerve palsy	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Agitation	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Psychiatric disorders Mental status changes	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Decubitus ulcer	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Ecchymosis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Rash papular	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Skin and subcutaneous tissue disorders Skin hypopigmentation	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Cardiac disorders Atrial flutter	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Ankle fracture	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Injury, poisoning and procedural complications Arthropod sting	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Bladder spasm	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Haematuria	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Incontinence	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Renal failure	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Renal and urinary disorders Urinary tract pain	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Vascular disorders Haematoma	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Ear and labyrinth disorders Tinnitus	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Ear and labyrinth disorders Vertigo	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Hepatobiliary disorders Cholelithiasis	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Hepatobiliary disorders Hepatobiliary disease	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Reproductive system and breast disorders Benign prostatic hyperplasia	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Reproductive system and breast disorders Calculus prostatic	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Reproductive system and breast disorders Penile pain	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Reproductive system and breast disorders Prostatic pain	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Social circumstances Immobile	5.9% 1/17 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/21 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/3 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	0.00% 0/12 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.	— 0/0 • All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2. Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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