Trial Outcomes & Findings for Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants (NCT NCT04640311)

Last Updated: 2025-04-10

Results Overview

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

259 participants

Primary outcome timeframe

Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

Results posted on

2025-04-10

Participant Flow

Participants were enrolled across 4 centers in the United States. This study consisted of two parts; Part A (3-period crossover study) and Part B (2-period crossover study).

A total of 259 participants (52 in Part A and 207 in Part B) were enrolled in the study (Safety Population: It comprised of all randomized participants who have taken at least 1 dose of study intervention).

Participant milestones

Participant milestones
Measure	Part A: Daprodustat DP 1 Process 2/Daprodustat DP 2 Process 2/Daprodustat Process 1 Participants received a single oral dose of daprodustat 4 milligrams (mg) tablets with dissolution profile (DP) 1 made by Process 2 (high shear wet granulation) in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets made by reference Process 1 (twin screw granulation) in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part A: Daprodustat DP 2 Process 2/ Daprodustat Process 1 / Daprodustat DP 1 Process 2 Participants received a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part A: Daprodustat Process 1 / Daprodustat DP 1 Process 2/ Daprodustat DP 2 Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part B: Daprodustat 1 mg Process 2/ Daprodustat 1 mg Process 1 Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 1 mg Process 1/Daprodustat 1 mg Process 2 Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 2 mg Process 2/Daprodustat 2 mg Process 1 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 2 mg Process 1/ Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 4 mg Process 2/ Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 4 mg Process 1/Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 6 mg Process 2/Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 6 mg Process 1/Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 8 mg Process 2/Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 8 mg Process 1/Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
Part A:Treatment Period 1 (Up to 2 Days) STARTED	16	18	18	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 1 (Up to 2 Days) COMPLETED	15	16	18	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 1 (Up to 2 Days) NOT COMPLETED	1	2	0	0	0	0	0	0	0	0	0	0	0
Part A: Washout 1 (Up to 7 Days) STARTED	15	16	18	0	0	0	0	0	0	0	0	0	0
Part A: Washout 1 (Up to 7 Days) COMPLETED	15	16	18	0	0	0	0	0	0	0	0	0	0
Part A: Washout 1 (Up to 7 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 2 (Up to 2 Days) STARTED	15	16	18	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 2 (Up to 2 Days) COMPLETED	12	11	10	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 2 (Up to 2 Days) NOT COMPLETED	3	5	8	0	0	0	0	0	0	0	0	0	0
Part A: Washout 2 (Up to 7 Days) STARTED	12	11	10	0	0	0	0	0	0	0	0	0	0
Part A: Washout 2 (Up to 7 Days) COMPLETED	12	11	10	0	0	0	0	0	0	0	0	0	0
Part A: Washout 2 (Up to 7 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 3 (Up to 2 Days) STARTED	12	11	10	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 3 (Up to 2 Days) COMPLETED	12	11	10	0	0	0	0	0	0	0	0	0	0
Part A:Treatment Period 3 (Up to 2 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Part B:Treatment Period 1 (Up to 2 Days) STARTED	0	0	0	21	19	21	22	21	21	21	21	20	20
Part B:Treatment Period 1 (Up to 2 Days) COMPLETED	0	0	0	20	19	20	20	21	19	21	20	20	20
Part B:Treatment Period 1 (Up to 2 Days) NOT COMPLETED	0	0	0	1	0	1	2	0	2	0	1	0	0
Part B: Washout 1 (Up to 7 Days) STARTED	0	0	0	20	19	20	20	21	19	21	20	20	20
Part B: Washout 1 (Up to 7 Days) COMPLETED	0	0	0	20	19	20	20	21	19	21	20	20	20
Part B: Washout 1 (Up to 7 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Part B: Treatment Period 2(Up to 2 Days) STARTED	0	0	0	20	19	20	20	21	19	21	20	20	20
Part B: Treatment Period 2(Up to 2 Days) COMPLETED	0	0	0	20	19	20	20	21	19	21	20	19	20
Part B: Treatment Period 2(Up to 2 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Daprodustat DP 1 Process 2/Daprodustat DP 2 Process 2/Daprodustat Process 1 Participants received a single oral dose of daprodustat 4 milligrams (mg) tablets with dissolution profile (DP) 1 made by Process 2 (high shear wet granulation) in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets made by reference Process 1 (twin screw granulation) in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part A: Daprodustat DP 2 Process 2/ Daprodustat Process 1 / Daprodustat DP 1 Process 2 Participants received a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part A: Daprodustat Process 1 / Daprodustat DP 1 Process 2/ Daprodustat DP 2 Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part B: Daprodustat 1 mg Process 2/ Daprodustat 1 mg Process 1 Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 2 mg Process 2/Daprodustat 2 mg Process 1 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 2 mg Process 1/ Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 4 mg Process 1/Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 6 mg Process 1/Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 8 mg Process 2/Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
Part A:Treatment Period 1 (Up to 2 Days) Physician Decision	1	0	0	0	0	0	0	0	0
Part A:Treatment Period 1 (Up to 2 Days) Protocol Violation	0	1	0	0	0	0	0	0	0
Part A:Treatment Period 1 (Up to 2 Days) Withdrawn by sponsor due to impact of inclement weather events	0	1	0	0	0	0	0	0	0
Part A:Treatment Period 2 (Up to 2 Days) Withdrawn by sponsor due to impact of inclement weather events	3	5	6	0	0	0	0	0	0
Part A:Treatment Period 2 (Up to 2 Days) Adverse Event	0	0	2	0	0	0	0	0	0
Part B:Treatment Period 1 (Up to 2 Days) Withdrawal by Subject	0	0	0	1	0	1	0	0	0
Part B:Treatment Period 1 (Up to 2 Days) Physician Decision	0	0	0	0	1	0	2	0	0
Part B:Treatment Period 1 (Up to 2 Days) Adverse Event	0	0	0	0	0	1	0	1	0
Part B: Treatment Period 2(Up to 2 Days) Withdrawal by Subject	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Daprodustat DP 1 Process 2/Daprodustat DP 2 Process 2/Daprodustat Process 1 n=16 Participants Participants received a single oral dose of daprodustat 4 milligrams (mg) tablets with dissolution profile (DP) 1 made by Process 2 (high shear wet granulation) in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets made by reference Process 1 (twin screw granulation) in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part A: Daprodustat DP 2 Process 2/ Daprodustat Process 1 / Daprodustat DP 1 Process 2 n=18 Participants Participants received a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part A: Daprodustat Process 1 / Daprodustat DP 1 Process 2/ Daprodustat DP 2 Process 2 n=18 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.	Part B: Daprodustat 1 mg Process 2/ Daprodustat 1 mg Process 1 n=21 Participants Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 1 mg Process 1/Daprodustat 1 mg Process 2 n=19 Participants Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 2 mg Process 2/Daprodustat 2 mg Process 1 n=21 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 2 mg Process 1/ Daprodustat 2 mg Process 2 n=22 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 4 mg Process 2/ Daprodustat 4 mg Process 1 n=21 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 4 mg Process 1/Daprodustat 4 mg Process 2 n=21 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 6 mg Process 2/Daprodustat 6 mg Process 1 n=21 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 6 mg Process 1/Daprodustat 6 mg Process 2 n=21 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 8 mg Process 2/Daprodustat 8 mg Process 1 n=20 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Part B: Daprodustat 8 mg Process 1/Daprodustat 8 mg Process 2 n=20 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.	Total n=259 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	21 Participants n=4 Participants	19 Participants n=21 Participants	21 Participants n=8 Participants	22 Participants n=8 Participants	21 Participants n=24 Participants	21 Participants n=42 Participants	21 Participants n=42 Participants	21 Participants n=42 Participants	20 Participants n=42 Participants	20 Participants n=36 Participants	259 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	11 Participants n=8 Participants	10 Participants n=8 Participants	4 Participants n=24 Participants	8 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	4 Participants n=36 Participants	86 Participants n=36 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	12 Participants n=21 Participants	10 Participants n=8 Participants	12 Participants n=8 Participants	17 Participants n=24 Participants	13 Participants n=42 Participants	15 Participants n=42 Participants	17 Participants n=42 Participants	15 Participants n=42 Participants	16 Participants n=36 Participants	173 Participants n=36 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	9 Participants n=36 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	9 Participants n=8 Participants	9 Participants n=8 Participants	11 Participants n=24 Participants	13 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	12 Participants n=42 Participants	17 Participants n=36 Participants	111 Participants n=36 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	4 Participants n=36 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized White - Arabic/ North African Heritage	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	12 Participants n=36 Participants
Race/Ethnicity, Customized White - White/ Caucasian/ European Heritage	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	9 Participants n=24 Participants	3 Participants n=42 Participants	13 Participants n=42 Participants	14 Participants n=42 Participants	7 Participants n=42 Participants	3 Participants n=36 Participants	100 Participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized Asian - Central/ South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	4 Participants n=36 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	9 Participants n=36 Participants
Race/Ethnicity, Customized Asian - Mixed Race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

Population: Pharmacokinetic Population comprised of all participants in the Safety Population (All randomized participants who have taken at least 1 dose of study intervention) who had at least 1 non-missing Pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat	155.5 Hours*nanograms per milliliter Geometric Coefficient of Variation 14.7	159.9 Hours*nanograms per milliliter Geometric Coefficient of Variation 14.7	158.5 Hours*nanograms per milliliter Geometric Coefficient of Variation 14.7	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

Population: Pharmacokinetic Population

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: AUC(0-t) Following Administration of Daprodustat	36.97 Hours*nanograms per milliliter Geometric Coefficient of Variation 13.5	38.02 Hours*nanograms per milliliter Geometric Coefficient of Variation 13.5	83.27 Hours*nanograms per milliliter Geometric Coefficient of Variation 17.0	79.08 Hours*nanograms per milliliter Geometric Coefficient of Variation 17.0	132.9 Hours*nanograms per milliliter Geometric Coefficient of Variation 15.4	134.2 Hours*nanograms per milliliter Geometric Coefficient of Variation 15.4	249.5 Hours*nanograms per milliliter Geometric Coefficient of Variation 16.3	241.5 Hours*nanograms per milliliter Geometric Coefficient of Variation 16.3	292.8 Hours*nanograms per milliliter Geometric Coefficient of Variation 16.3	278.5 Hours*nanograms per milliliter Geometric Coefficient of Variation 16.3

PRIMARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

Population: Pharmacokinetic Population

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: Maximum Observed Plasma Concentration (Cmax) Following Administration of Daprodustat	68.22 Nanograms per milliliter Geometric Coefficient of Variation 28.7	71.06 Nanograms per milliliter Geometric Coefficient of Variation 28.7	71.51 Nanograms per milliliter Geometric Coefficient of Variation 28.7	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

Population: Pharmacokinetic Population

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: Cmax Following Administration of Daprodustat	17.90 Nanograms per milliliter Geometric Coefficient of Variation 22.2	17.39 Nanograms per milliliter Geometric Coefficient of Variation 22.2	39.20 Nanograms per milliliter Geometric Coefficient of Variation 28.8	35.30 Nanograms per milliliter Geometric Coefficient of Variation 28.8	62.05 Nanograms per milliliter Geometric Coefficient of Variation 30.9	60.21 Nanograms per milliliter Geometric Coefficient of Variation 30.9	113.4 Nanograms per milliliter Geometric Coefficient of Variation 26.7	109.7 Nanograms per milliliter Geometric Coefficient of Variation 26.7	139.5 Nanograms per milliliter Geometric Coefficient of Variation 27.6	120.0 Nanograms per milliliter Geometric Coefficient of Variation 27.6

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=33 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: AUC From Zero Time (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) Following Administration of Daprodustat	159.9 Hours* nanograms per milliliter Geometric Coefficient of Variation 34.7	162.5 Hours* nanograms per milliliter Geometric Coefficient of Variation 31.5	161.5 Hours* nanograms per milliliter Geometric Coefficient of Variation 34.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

Population: Pharmacokinetic Population

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: Time of Occurrence of Cmax (Tmax) Following Administration of Daprodustat	2.500 Hours Interval 0.5 to 8.0	2.000 Hours Interval 1.0 to 6.0	2.000 Hours Interval 1.0 to 4.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=33 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: Terminal Phase Half-life (T1/2) Following Administration of Daprodustat	1.797 Hours Geometric Coefficient of Variation 28.9	1.910 Hours Geometric Coefficient of Variation 25.0	1.932 Hours Geometric Coefficient of Variation 34.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=33 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: Apparent Clearance Following Oral Administration of Daprodustat	25.02 Liters per hour Geometric Coefficient of Variation 34.7	24.61 Liters per hour Geometric Coefficient of Variation 31.5	24.77 Liters per hour Geometric Coefficient of Variation 34.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=34 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=35 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=33 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part A: Apparent Volume of Distribution Following Oral Administration of Daprodustat	64.87 Liters Geometric Coefficient of Variation 42.4	67.81 Liters Geometric Coefficient of Variation 47.3	69.05 Liters Geometric Coefficient of Variation 50.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=36 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=37 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: AUC(0-inf) Following Administration of Daprodustat	37.71 Hours* nanograms per milliliter Geometric Coefficient of Variation 33.1	38.81 Hours* nanograms per milliliter Geometric Coefficient of Variation 37.8	84.36 Hours* nanograms per milliliter Geometric Coefficient of Variation 36.0	78.59 Hours* nanograms per milliliter Geometric Coefficient of Variation 34.1	135.5 Hours* nanograms per milliliter Geometric Coefficient of Variation 32.7	135.2 Hours* nanograms per milliliter Geometric Coefficient of Variation 33.0	250.4 Hours* nanograms per milliliter Geometric Coefficient of Variation 38.7	246.0 Hours* nanograms per milliliter Geometric Coefficient of Variation 40.5	295.8 Hours* nanograms per milliliter Geometric Coefficient of Variation 38.5	282.7 Hours* nanograms per milliliter Geometric Coefficient of Variation 39.3

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

Population: Pharmacokinetic Population

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: Tmax Following Administration of Daprodustat	2.000 Hours Interval 0.5 to 4.0	2.000 Hours Interval 0.517 to 4.0	2.250 Hours Interval 1.0 to 4.0	2.000 Hours Interval 0.5 to 4.0	2.000 Hours Interval 1.0 to 4.0	2.000 Hours Interval 0.5 to 4.0	2.000 Hours Interval 0.5 to 4.0	1.000 Hours Interval 0.5 to 4.0	2.000 Hours Interval 1.0 to 4.0	2.000 Hours Interval 0.5 to 6.0

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=36 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=37 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: T1/2 Following Administration of Daprodustat	1.162 Hours Geometric Coefficient of Variation 28.2	1.163 Hours Geometric Coefficient of Variation 30.2	1.545 Hours Geometric Coefficient of Variation 32.3	1.489 Hours Geometric Coefficient of Variation 32.6	1.814 Hours Geometric Coefficient of Variation 31.2	1.775 Hours Geometric Coefficient of Variation 26.5	1.852 Hours Geometric Coefficient of Variation 24.5	1.920 Hours Geometric Coefficient of Variation 24.4	1.997 Hours Geometric Coefficient of Variation 35.3	2.136 Hours Geometric Coefficient of Variation 35.0

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=36 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=37 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: Apparent Clearance Following Oral Administration of Daprodustat	26.52 Liters per hour Geometric Coefficient of Variation 33.1	25.76 Liters per hour Geometric Coefficient of Variation 37.8	23.71 Liters per hour Geometric Coefficient of Variation 36.0	25.45 Liters per hour Geometric Coefficient of Variation 34.1	29.53 Liters per hour Geometric Coefficient of Variation 32.7	29.58 Liters per hour Geometric Coefficient of Variation 33.0	23.96 Liters per hour Geometric Coefficient of Variation 38.7	24.39 Liters per hour Geometric Coefficient of Variation 40.5	27.04 Liters per hour Geometric Coefficient of Variation 38.5	28.30 Liters per hour Geometric Coefficient of Variation 39.3

SECONDARY outcome

Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2

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

Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Part A: Daprodustat Process 1 n=36 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=37 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=42 Participants Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 2 mg Process 2 n=41 Participants Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=40 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=40 Participants Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=39 Participants Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Part B: Apparent Volume of Distribution Following Oral Administration of Daprodustat	44.45 Liters Geometric Coefficient of Variation 31.7	43.22 Liters Geometric Coefficient of Variation 43.6	52.83 Liters Geometric Coefficient of Variation 43.1	54.65 Liters Geometric Coefficient of Variation 30.9	77.28 Liters Geometric Coefficient of Variation 43.9	75.74 Liters Geometric Coefficient of Variation 40.3	64.02 Liters Geometric Coefficient of Variation 37.1	67.56 Liters Geometric Coefficient of Variation 38.9	77.92 Liters Geometric Coefficient of Variation 54.5	87.21 Liters Geometric Coefficient of Variation 42.6

Adverse Events

Part A: Daprodustat Process 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: Daprodustat Process 2 Dissolution Profile 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: Daprodustat Process 2 Dissolution Profile 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B: Daprodustat 1 mg Process 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Daprodustat 1 mg Process 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Daprodustat 2 mg Process 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Daprodustat 2 mg Process 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Daprodustat 4 mg Process 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Daprodustat 4 mg Process 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B: Daprodustat 6 mg Process 1

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B: Daprodustat 6 mg Process 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Daprodustat 8 mg Process 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B: Daprodustat 8 mg Process 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Daprodustat Process 1 n=46 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=45 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=43 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 1 mg Process 1 n=39 participants at risk Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 1 mg Process 2 n=40 participants at risk Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 2 mg Process 1 n=42 participants at risk Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 2 mg Process 2 n=41 participants at risk Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=42 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=40 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 participants at risk Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=41 participants at risk Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=40 participants at risk Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=40 participants at risk Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.

Other adverse events

Other adverse events
Measure	Part A: Daprodustat Process 1 n=46 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 1 n=45 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part A: Daprodustat Process 2 Dissolution Profile 2 n=43 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.	Part B: Daprodustat 1 mg Process 1 n=39 participants at risk Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 1 mg Process 2 n=40 participants at risk Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 2 mg Process 1 n=42 participants at risk Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 2 mg Process 2 n=41 participants at risk Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 1 n=42 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 4 mg Process 2 n=40 participants at risk Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 1 n=42 participants at risk Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 6 mg Process 2 n=41 participants at risk Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 1 n=40 participants at risk Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.	Part B: Daprodustat 8 mg Process 2 n=40 participants at risk Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Investigations SARS-CoV-2 test positive	2.2% 1/46 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.2% 1/45 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Gastrointestinal disorders Flatulence	2.2% 1/46 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
General disorders Feeling of body temperature change	2.2% 1/46 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Nervous system disorders Dizziness	2.2% 1/46 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	4.8% 2/42 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Psychiatric disorders Anxiety	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.2% 1/45 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
General disorders Feeling jittery	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.6% 1/39 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Injury, poisoning and procedural complications Fall	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Investigations Blood pressure increased	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Nervous system disorders Tremor	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Nervous system disorders Headache	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	4.8% 2/42 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/41 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/41 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/41 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Investigations Alanine aminotransferase increased	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Investigations Aspartate aminotransferase increased	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	4.8% 2/42 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
General disorders Vessel puncture site haemorrhage	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
General disorders Vessel puncture site pain	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Gastrointestinal disorders Abdominal distension	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Infections and infestations COVID-19	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Infections and infestations Urinary tract infection	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Metabolism and nutrition disorders Gout	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Gastrointestinal disorders Dyspepsia	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	5.0% 2/40 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Gastrointestinal disorders Diarrhoea	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.5% 1/40 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.2% 1/45 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
Gastrointestinal disorders Nausea	0.00% 0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/45 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/43 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/42 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	2.4% 1/42 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/41 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.	0.00% 0/40 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study. Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.

Additional Information

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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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