Trial Outcomes & Findings for A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer (NCT NCT01847274)

Last Updated: 2023-06-02

Results Overview

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

596 participants

Primary outcome timeframe

From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days

Results posted on

2023-06-02

Participant Flow

This was a randomized, double-blind study conducted to analyze maintenance with niraparib versus placebo in participants with ovarian cancer.

A total of 596 participants were enrolled in the study. The results presented are based on the data cut-off date of 31 March 2021 (which aligns with the time of the study unblinding) and the post-unblinding safety data until the end of study (01-April-2021 to 26-December-2021).

Participant milestones

Participant milestones
Measure	gBRCA Niraparib Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	gBRCA Placebo Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression	FE Sub-study: Fasted/Fed Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods.	FE Sub-study: Fed/Fasted Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods.	QTc Sub-study: Niraparib Participants received Niraparib 300 mg once daily orally.	gBRCA Niraparib (Post-study Unblinding [PSU]) Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	gBRCA Placebo (PSU) Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Niraparib (PSU) Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Placebo (PSU) Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Main Study (Upto 7years 7months 6 Days) STARTED	138	65	234	116	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) NOT COMPLETED	138	65	234	116	0	0	0	0	0	0	0
FE Sub-study, Period1 (Day1) STARTED	0	0	0	0	8	9	0	0	0	0	0
FE Sub-study, Period1 (Day1) COMPLETED	0	0	0	0	8	8	0	0	0	0	0
FE Sub-study, Period1 (Day1) NOT COMPLETED	0	0	0	0	0	1	0	0	0	0	0
FE Sub-study, Washout 1 (Up to Day 7) STARTED	0	0	0	0	8	8	0	0	0	0	0
FE Sub-study, Washout 1 (Up to Day 7) COMPLETED	0	0	0	0	7	8	0	0	0	0	0
FE Sub-study, Washout 1 (Up to Day 7) NOT COMPLETED	0	0	0	0	1	0	0	0	0	0	0
FE Sub-study, Period 2 (Day 1) STARTED	0	0	0	0	7	8	0	0	0	0	0
FE Sub-study, Period 2 (Day 1) COMPLETED	0	0	0	0	7	8	0	0	0	0	0
FE Sub-study, Period 2 (Day 1) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
QTcSub-study(Upto 5 Year,10 Month,22day) STARTED	0	0	0	0	0	0	26	0	0	0	0
QTcSub-study(Upto 5 Year,10 Month,22day) COMPLETED	0	0	0	0	0	0	0	0	0	0	0
QTcSub-study(Upto 5 Year,10 Month,22day) NOT COMPLETED	0	0	0	0	0	0	26	0	0	0	0
Main Study PSU (Up to 8months, 26days) STARTED	0	0	0	0	0	0	0	22	8	31	13
Main Study PSU (Up to 8months, 26days) COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Main Study PSU (Up to 8months, 26days) NOT COMPLETED	0	0	0	0	0	0	0	22	8	31	13

Reasons for withdrawal

Reasons for withdrawal
Measure	gBRCA Niraparib Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	gBRCA Placebo Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression	FE Sub-study: Fasted/Fed Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods.	FE Sub-study: Fed/Fasted Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods.	QTc Sub-study: Niraparib Participants received Niraparib 300 mg once daily orally.	gBRCA Niraparib (Post-study Unblinding [PSU]) Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	gBRCA Placebo (PSU) Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Niraparib (PSU) Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Placebo (PSU) Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Main Study (Upto 7years 7months 6 Days) Ongoing at the time of analysis	22	8	31	13	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) Withdrawal by Subject	20	11	29	14	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) Lost to Follow-up	7	2	5	1	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) Disease progression	0	0	0	2	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) Subject unblinded by sponsor	12	12	15	14	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) Death	72	29	146	68	0	0	0	0	0	0	0
Main Study (Upto 7years 7months 6 Days) Other reasons	5	3	8	4	0	0	0	0	0	0	0
FE Sub-study, Period1 (Day1) Adverse Event	0	0	0	0	0	1	0	0	0	0	0
FE Sub-study, Washout 1 (Up to Day 7) Transferred to Other Arm/Group	0	0	0	0	1	0	0	0	0	0	0
QTcSub-study(Upto 5 Year,10 Month,22day) Withdrawal by Subject	0	0	0	0	0	0	4	0	0	0	0
QTcSub-study(Upto 5 Year,10 Month,22day) Death	0	0	0	0	0	0	5	0	0	0	0
QTcSub-study(Upto 5 Year,10 Month,22day) Other Reasons	0	0	0	0	0	0	17	0	0	0	0
Main Study PSU (Up to 8months, 26days) Subject Unblinded by Sponsor	0	0	0	0	0	0	0	15	8	18	12
Main Study PSU (Up to 8months, 26days) Subject Moved to Rollover Study	0	0	0	0	0	0	0	6	0	9	0
Main Study PSU (Up to 8months, 26days) Other reasons	0	0	0	0	0	0	0	1	0	3	1
Main Study PSU (Up to 8months, 26days) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib n=234 Participants Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo n=116 Participants Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression	FE Sub-study: Fasted/Fed n=8 Participants Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods.	FE Sub-study: Fed/Fasted n=9 Participants Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods.	QTc Sub-study: Niraparib n=26 Participants Participants received Niraparib 300 mg once daily orally.	Total n=596 Participants Total of all reporting groups
Age, Customized <=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
Age, Customized Between 18 and 64 years	110 Participants n=5 Participants	49 Participants n=7 Participants	130 Participants n=5 Participants	69 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	16 Participants n=8 Participants	384 Participants n=24 Participants
Age, Customized >=65 years	28 Participants n=5 Participants	16 Participants n=7 Participants	104 Participants n=5 Participants	47 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	10 Participants n=8 Participants	212 Participants n=24 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	65 Participants n=7 Participants	234 Participants n=5 Participants	116 Participants n=4 Participants	8 Participants n=21 Participants	9 Participants n=8 Participants	26 Participants n=8 Participants	596 Participants n=24 Participants
Sex: Female, Male Male	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
Race/Ethnicity, Customized American Indian or Alaska Native	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	2 Participants n=24 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	20 Participants n=24 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	11 Participants n=24 Participants
Race/Ethnicity, Customized White	123 Participants n=5 Participants	55 Participants n=7 Participants	201 Participants n=5 Participants	101 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=8 Participants	21 Participants n=8 Participants	516 Participants n=24 Participants
Race/Ethnicity, Customized Unknown or Not Reported	11 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	46 Participants n=24 Participants

PRIMARY outcome

Timeframe: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days

Population: Intent-to-treat population was defined as all randomized participants with participants analyzed according to the study drug assigned via randomization

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)	5.5 months Interval 3.8 to 7.2	21 months Interval 12.9 to Upper limit of confidence interval (CI) was not estimable as upper limits of CI for survivor function were above 0.5 (SAS PROC LIFETEST).	—	—

PRIMARY outcome

Timeframe: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=56 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=106 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)	3.8 months Interval 3.5 to 5.7	12.9 months Interval 8.1 to 15.9	—	—

PRIMARY outcome

Timeframe: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation	3.9 Months Interval 3.7 to 5.5	9.3 Months Interval 7.2 to 11.2	—	—

SECONDARY outcome

Timeframe: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)	8.6 Months Interval 6.9 to 12.2	19.1 Months Interval 14.6 to 21.9	—	—

SECONDARY outcome

Timeframe: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation	7.4 Months Interval 5.9 to 8.7	12.4 Months Interval 10.9 to 14.5	—	—

SECONDARY outcome

Timeframe: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population

Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)	9.4 Months Interval 7.9 to 10.4	20.0 Months Interval 16.2 to 23.3	—	—

SECONDARY outcome

Timeframe: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation	8.7 Months Interval 6.9 to 10.0	13.4 Months Interval 11.3 to 14.8	—	—

SECONDARY outcome

Timeframe: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)	22.7 Months Interval 19.5 to 25.9	29.9 Months Interval 24.8 to 33.4	—	—

SECONDARY outcome

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation	16.1 Months Interval 13.6 to 22.8	19.5 Months Interval 17.1 to 22.3	—	—

SECONDARY outcome

Timeframe: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

Overall survival was defined as the date of randomization to the date of death by any cause.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)	38.1 Months Interval 27.6 to 47.3	40.9 Months Interval 34.9 to 52.9	—	—

SECONDARY outcome

Timeframe: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

Overall survival was defined as the date of randomization to the date of death by any cause.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Survival in Cohort With No Germline BRCA Mutation	34.8 Months Interval 27.9 to 41.4	31.0 Months Interval 27.8 to 35.6	—	—

SECONDARY outcome

Timeframe: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)	19.6 Months Interval 14.4 to 25.5	29.7 Months Interval 23.3 to 33.4	—	—

SECONDARY outcome

Timeframe: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days

Population: Intent-to-treat population

TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation	16.7 Months Interval 14.9 to 21.3	20.3 Months Interval 18.0 to 23.4	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=55 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=114 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2	-0.3 Scores on a scale Standard Deviation 3.19	-0.8 Scores on a scale Standard Deviation 4.58	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=43 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=109 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4	-0.3 Scores on a scale Standard Deviation 3.88	-0.1 Scores on a scale Standard Deviation 4.07	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=36 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=95 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6	-0.5 Scores on a scale Standard Deviation 4.27	0.5 Scores on a scale Standard Deviation 3.77	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=37 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=80 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression	-1.324 Scores on a scale Standard Deviation 4.5034	-0.751 Scores on a scale Standard Deviation 4.4342	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=97 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=181 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2	-0.3 Scores on a scale Standard Deviation 2.84	-1.0 Scores on a scale Standard Deviation 3.79	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=77 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=150 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4	-0.9 Scores on a scale Standard Deviation 4.23	-0.7 Scores on a scale Standard Deviation 4.16	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=50 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=124 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6	-0.9 Scores on a scale Standard Deviation 3.43	-0.2 Scores on a scale Standard Deviation 3.76	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=82 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=146 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression	-1.801 Scores on a scale Standard Deviation 4.0290	-2.595 Scores on a scale Standard Deviation 5.5700	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=59 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=118 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2	-0.008 Scores on a scale Standard Deviation 0.1354	-0.008 Scores on a scale Standard Deviation 0.1092	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=44 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=113 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4	-0.035 Scores on a scale Standard Deviation 0.1156	-0.010 Scores on a scale Standard Deviation 0.1225	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=36 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=99 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6	-0.004 Scores on a scale Standard Deviation 0.1463	0.002 Scores on a scale Standard Deviation 0.1116	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=38 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=81 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression	-0.013 Scores on a scale Standard Deviation 0.1580	-0.041 Scores on a scale Standard Deviation 0.1192	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=96 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=185 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2	-0.011 Scores on a scale Standard Deviation 0.1015	-0.007 Scores on a scale Standard Deviation 0.1013	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=80 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=155 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4	-0.014 Scores on a scale Standard Deviation 0.0870	-0.004 Scores on a scale Standard Deviation 0.1077	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=50 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=127 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6	-0.011 Scores on a scale Standard Deviation 0.0949	0.005 Scores on a scale Standard Deviation 0.1097	—	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=84 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=149 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression	-0.050 Scores on a scale Standard Deviation 0.1351	-0.047 Scores on a scale Standard Deviation 0.1355	—	—

SECONDARY outcome

Timeframe: At Baseline

Population: Intent-to-treat Population.

A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=138 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Feet, 0-Not at all	26 Participants	47 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Feet, 1-A little bit	12 Participants	32 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Feet, 2-Somewhat	9 Participants	24 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Feet, 3-Quite a bit	10 Participants	21 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Feet, 4-Very much	6 Participants	9 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Hands, 0-Not at all	37 Participants	80 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Hands, 1-A little bit	13 Participants	28 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Hands, 2-Somewhat	6 Participants	8 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Hands, 3-Quite a bit	5 Participants	14 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline Hands, 4-Very much	2 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: At Cycle 2 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=64 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=132 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Feet, 0-Not at all	25 Participants	48 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Feet, 1-A little bit	5 Participants	22 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Feet, 2-Somewhat	15 Participants	17 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Feet, 3-Quite a bit	10 Participants	20 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Feet, 4-Very much	3 Participants	8 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Hands, 0-Not at all	31 Participants	73 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Hands, 1-A little bit	16 Participants	19 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Hands, 2-Somewhat	6 Participants	13 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Hands, 3-Quite a bit	2 Participants	7 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2 Hands, 4-Very much	2 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: At Cycle 4 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=54 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=120 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Feet, 0-Not at all	20 Participants	47 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Feet, 1-A little bit	6 Participants	22 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Feet, 2-Somewhat	7 Participants	20 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Feet, 3-Quite a bit	8 Participants	15 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Feet, 4-Very much	2 Participants	6 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Hands, 0-Not at all	29 Participants	70 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Hands, 1-A little bit	6 Participants	18 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Hands, 2-Somewhat	3 Participants	16 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Hands, 3-Quite a bit	4 Participants	4 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4 Hands, 4-Very much	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: At Cycle 6 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=41 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=105 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Feet, 0-Not at all	17 Participants	44 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Feet, 1-A little bit	5 Participants	17 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Feet, 2-Somewhat	7 Participants	13 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Feet, 3-Quite a bit	5 Participants	15 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Feet, 4-Very much	2 Participants	9 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Hands, 0-Not at all	21 Participants	54 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Hands, 1-A little bit	8 Participants	25 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Hands, 2-Somewhat	4 Participants	10 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Hands, 3-Quite a bit	2 Participants	6 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6 Hands, 4-Very much	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=49 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=104 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Hands, 2-Somewhat	3 Participants	8 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Feet, 0-Not at all	15 Participants	31 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Feet, 1-A little bit	9 Participants	20 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Feet, 2-Somewhat	3 Participants	7 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Feet, 3-Quite a bit	7 Participants	15 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Feet, 4-Very much	3 Participants	7 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Hands, 0-Not at all	26 Participants	44 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Hands, 1-A little bit	4 Participants	18 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Hands, 3-Quite a bit	4 Participants	7 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression Hands, 4-Very much	0 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: At Baseline

Population: Intent-to-treat Population.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=116 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=234 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Feet, 0-Not at all	40 Participants	71 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Feet, 1-A little bit	26 Participants	58 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Feet, 2-Somewhat	16 Participants	37 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Feet, 3-Quite a bit	21 Participants	43 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Feet, 4-Very much	9 Participants	18 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Hands, 0-Not at all	48 Participants	120 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Hands, 1-A little bit	37 Participants	56 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Hands, 2-Somewhat	12 Participants	28 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Hands, 3-Quite a bit	11 Participants	15 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline Hands, 4-Very much	2 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: At Cycle 2 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=113 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=212 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Hands, 1-A little bit	24 Participants	38 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Hands, 2-Somewhat	19 Participants	20 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Feet, 0-Not at all	32 Participants	69 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Feet, 1-A little bit	17 Participants	39 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Feet, 2-Somewhat	12 Participants	30 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Feet, 3-Quite a bit	18 Participants	34 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Feet, 4-Very much	8 Participants	9 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Hands, 0-Not at all	44 Participants	100 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Hands, 3-Quite a bit	5 Participants	17 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2 Hands, 4-Very much	3 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: At Cycle 4 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=95 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=181 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Feet, 0-Not at all	31 Participants	54 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Feet, 1-A little bit	16 Participants	37 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Feet, 2-Somewhat	17 Participants	34 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Feet, 3-Quite a bit	11 Participants	20 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Feet, 4-Very much	5 Participants	9 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Hands, 0-Not at all	43 Participants	89 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Hands, 1-A little bit	21 Participants	29 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Hands, 2-Somewhat	10 Participants	14 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Hands, 3-Quite a bit	3 Participants	14 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4 Hands, 4-Very much	1 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: At Cycle 6 (Each cycle was of 28 days)

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=56 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=144 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Feet, 0-Not at all	16 Participants	43 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Feet, 1-A little bit	10 Participants	29 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Feet, 2-Somewhat	11 Participants	30 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Feet, 3-Quite a bit	9 Participants	18 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Feet, 4-Very much	5 Participants	5 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Hands, 0-Not at all	29 Participants	68 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Hands, 1-A little bit	10 Participants	30 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Hands, 2-Somewhat	6 Participants	13 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Hands, 3-Quite a bit	5 Participants	9 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6 Hands, 4-Very much	0 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=105 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=185 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Feet, 3-Quite a bit	16 Participants	19 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Feet, 0-Not at all	32 Participants	57 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Feet, 1-A little bit	12 Participants	45 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Feet, 2-Somewhat	16 Participants	23 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Feet, 4-Very much	8 Participants	5 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Hands, 0-Not at all	48 Participants	88 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Hands, 1-A little bit	15 Participants	35 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Hands, 2-Somewhat	9 Participants	13 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Hands, 3-Quite a bit	10 Participants	7 Participants	—	—
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression Hands, 4-Very much	1 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population.

This will never be analyzed since the data for the candidate companion BRAC analysis diagnostic test was not collected which was to be compared with centralized BRCA mutation test used in this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years, 7 months and 4 days

Population: Intent-to-treat Population.

This will never be analyzed since the data for the candidate companion HRD diagnostic test was not collected which was to be compared with HRD test used in this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years, 7 months and 6 days

Population: Safety Population consisted of all participants who ingested any amount of study drug.

An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. Data presented for this outcome measure is based on the data cut-off date of 31-March-2021, which aligns with the time of the study unblinding.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=65 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=136 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib n=231 Participants Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo n=114 Participants Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Non-serious AEs	62 Participants	136 Participants	231 Participants	110 Participants
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs) SAEs	9 Participants	51 Participants	76 Participants	20 Participants

SECONDARY outcome

Timeframe: Up to 8 months, 26 days

Population: Safety Population.

An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=8 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=22 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib n=31 Participants Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo n=13 Participants Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding) Non-serious AEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding) SAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years, 3 months and 11 days

Population: Safety Population

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=16 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=16 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Non-serious AEs and SAEs in FE Sub-study Non-serious AEs	6 Participants	4 Participants	—	—
Number of Participants With Non-serious AEs and SAEs in FE Sub-study SAEs	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to 5 years 10 months and 22 days

Population: Safety Population

Outcome measures

Outcome measures
Measure	gBRCA Placebo Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=26 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study Non-serious AEs	—	24 Participants	—	—
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study SAEs	—	12 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

Population: Pharmacokinetic population consisted of all participants who received at least one dose of study drug, with sufficient data available to calculate parameters. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=14 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=15 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)	31194 Nanograms*hour per milliliter Standard Deviation 16894.88	29016.1 Nanograms*hour per milliliter Standard Deviation 18405.23	—	—

SECONDARY outcome

Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

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

Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=15 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=16 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-last]) Following Administration of Niraparib (FE Sub-study)	27186.4 Nanograms*hour per milliliter Standard Deviation 14111.37	28638.1 Nanograms*hour per milliliter Standard Deviation 17911.86	—	—

SECONDARY outcome

Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

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

Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=15 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=16 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)	582.1 Nanograms per milliliter Standard Deviation 228.57	803.7 Nanograms per milliliter Standard Deviation 403.35	—	—

SECONDARY outcome

Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

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

Blood samples were collected at indicated time points to analyze the tmax of niraparib.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=15 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=16 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)	6.1 Hour Interval 1.2 to 23.0	3.1 Hour Interval 1.7 to 6.1	—	—

SECONDARY outcome

Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

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

Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.

Outcome measures

Outcome measures
Measure	gBRCA Placebo n=14 Participants Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=16 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)	47.9 Hour Standard Deviation 17.54	50.5 Hour Standard Deviation 17.87	—	—

SECONDARY outcome

Timeframe: At Baseline (Cycle 1 Day 1, each cycle was of 28 days)

Population: Safety Population

12-lead electrocardiogram was obtained at indicated time points using an automated electrocardiogram machine that measured QTcF interval. The number of participants with maximum post-Baseline ECG value exceeding the following limits have been reported: QTcF interval \>450 and \<= 480 milliseconds (msec) and \>500 msec.

Outcome measures

Outcome measures
Measure	gBRCA Placebo Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.	gBRCA Niraparib n=26 Participants Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	Non-gBRCA Niraparib Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds >450 msec	—	2 Participants	—	—
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds >480 msec	—	0 Participants	—	—
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds >500 msec	—	0 Participants	—	—

Adverse Events

gBRCA Niraparib

Serious events: 51 serious events

Other events: 136 other events

Deaths: 72 deaths

gBRCA Placebo

Serious events: 9 serious events

Other events: 62 other events

Deaths: 29 deaths

Non-gBRCA Niraparib

Serious events: 76 serious events

Other events: 231 other events

Deaths: 146 deaths

Non-gBRCA Placebo

Serious events: 20 serious events

Other events: 110 other events

Deaths: 68 deaths

FE Niraparib Fasted

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

FE Niraparib Fed

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

QTc Sub-study: Niraparib

Serious events: 12 serious events

Other events: 24 other events

Deaths: 5 deaths

gBRCA Niraparib (Post-study Unblinding [PSU])

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

gBRCA Placebo (PSU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-gBRCA Niraparib (PSU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-gBRCA Placebo (PSU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	gBRCA Niraparib n=136 participants at risk Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	gBRCA Placebo n=65 participants at risk Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression	Non-gBRCA Niraparib n=231 participants at risk Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo n=114 participants at risk Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression	FE Niraparib Fasted n=16 participants at risk Participants received Niraparib 300 mg in fasted condition	FE Niraparib Fed n=16 participants at risk Participants received Niraparib 300 mg in fed condition	QTc Sub-study: Niraparib n=26 participants at risk Participants received Niraparib 300 mg once daily orally.	gBRCA Niraparib (Post-study Unblinding [PSU]) n=22 participants at risk Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	gBRCA Placebo (PSU) n=8 participants at risk Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Niraparib (PSU) n=31 participants at risk Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Placebo (PSU) n=13 participants at risk Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Angina pectoris	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Coronary artery stenosis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Thrombocytopenia	13.2% 18/136 • Number of events 38 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.0% 23/231 • Number of events 36 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.5% 3/26 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Anaemia	2.9% 4/136 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.6% 13/231 • Number of events 15 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Neutropenia	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Pancytopenia	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Small intestinal obstruction	2.2% 3/136 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.6% 6/231 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Ascites	1.5% 2/136 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Nausea	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal pain	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal pain upper	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Constipation	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.3% 3/231 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Ileus paralytic	0.74% 1/136 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Intestinal obstruction	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Pancreatitis	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	4.4% 6/136 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	3.7% 5/136 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute erythroid leukaemia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Urinary tract infection	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Erysipelas	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Bronchitis	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Infection	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Pneumonia	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.3% 3/231 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Pyrexia	1.5% 2/136 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Mucosal inflammation	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Non-cardiac chest pain	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Hyperglycaemia	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Hypomagnesaemia	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Anxiety	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Behaviour disorder	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Suicide attempt	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Renal and urinary disorders Acute kidney injury	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Renal and urinary disorders Nephrolithiasis	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Renal and urinary disorders Hydronephrosis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Cardiac failure	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Tachycardia	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Neutrophil count decreased	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Troponin increased	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Hip fracture	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Depressed level of consciousness	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Vascular disorders Hypertensive crisis	0.74% 1/136 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Reproductive system and breast disorders Breast disorder	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Subileus	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal hernia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Malignant gastrointestinal obstruction	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Obstruction gastric	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Vomiting	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Pyelonephritis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Sepsis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Tracheobronchitis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Upper respiratory tract infection	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Wound infection	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Device related infection	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Empyema	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Influenza	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Undifferentiated sarcoma	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer recurrent	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Disease progression	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Pain	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders General physical health deterioration	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Pericardial effusion	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Sinus tachycardia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Post procedural discomfort	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Platelet count decreased	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.87% 2/231 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Transaminases increased	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Hepatobiliary disorders Cholecystitis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Hepatobiliary disorders Cholestasis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Hepatobiliary disorders Hepatic failure	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Syncope	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Transient ischaemic attack	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Hallucination	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Depression	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Immune system disorders Anaphylactoid reaction	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Product Issues Thrombosis in device	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Vascular disorders Peripheral artery thrombosis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.43% 1/231 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Oesophagitis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Procedural complication	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Product use complaint	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Renal and urinary disorders Renal failure	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.8% 1/26 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Diarrhoea	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Ileus	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal distension	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).

Other adverse events

Other adverse events
Measure	gBRCA Niraparib n=136 participants at risk Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.	gBRCA Placebo n=65 participants at risk Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression	Non-gBRCA Niraparib n=231 participants at risk Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.	Non-gBRCA Placebo n=114 participants at risk Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression	FE Niraparib Fasted n=16 participants at risk Participants received Niraparib 300 mg in fasted condition	FE Niraparib Fed n=16 participants at risk Participants received Niraparib 300 mg in fed condition	QTc Sub-study: Niraparib n=26 participants at risk Participants received Niraparib 300 mg once daily orally.	gBRCA Niraparib (Post-study Unblinding [PSU]) n=22 participants at risk Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	gBRCA Placebo (PSU) n=8 participants at risk Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Niraparib (PSU) n=31 participants at risk Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021	Non-gBRCA Placebo (PSU) n=13 participants at risk Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
General disorders Asthenia	19.9% 27/136 • Number of events 75 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.6% 36/231 • Number of events 81 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.4% 13/114 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Pyrexia	8.1% 11/136 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.9% 16/231 • Number of events 23 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 7/114 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Atrial fibrillation	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Eye disorders Dry eye	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Dysgeusia	8.8% 12/136 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 14/231 • Number of events 18 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.6% 3/114 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal pain upper	12.5% 17/136 • Number of events 26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	13.8% 9/65 • Number of events 12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.4% 24/231 • Number of events 36 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.9% 9/114 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal distension	2.9% 4/136 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.2% 6/65 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.0% 23/231 • Number of events 29 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	13.2% 15/114 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Dyspepsia	16.9% 23/136 • Number of events 37 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 10/65 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.5% 22/231 • Number of events 25 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.9% 9/114 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Dry mouth	14.0% 19/136 • Number of events 38 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	33.3% 2/6 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	8.2% 19/231 • Number of events 27 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Influenza like illness	5.9% 8/136 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Anaemia	54.4% 74/136 • Number of events 259 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 5/65 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	48.1% 111/231 • Number of events 328 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 7/114 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	46.2% 12/26 • Number of events 23 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Neutropenia	17.6% 24/136 • Number of events 77 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	18.2% 42/231 • Number of events 128 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.6% 3/114 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	38.5% 10/26 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Thrombocytopenia	9.6% 13/136 • Number of events 226 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	40.3% 93/231 • Number of events 256 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	— 0/0 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	50.0% 13/26 • Number of events 36 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal pain	25.0% 34/136 • Number of events 50 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	26.2% 17/65 • Number of events 24 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	27.3% 63/231 • Number of events 93 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	34.2% 39/114 • Number of events 50 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	26.9% 7/26 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Ascites	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Constipation	41.2% 56/136 • Number of events 105 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	18.5% 12/65 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	41.6% 96/231 • Number of events 163 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	20.2% 23/114 • Number of events 30 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	34.6% 9/26 • Number of events 12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Diarrhoea	29.4% 40/136 • Number of events 71 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	23.1% 15/65 • Number of events 28 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	19.0% 44/231 • Number of events 76 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	20.2% 23/114 • Number of events 34 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Flatulence	5.1% 7/136 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.2% 12/231 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.9% 9/114 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Nausea	77.9% 106/136 • Number of events 205 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	35.4% 23/65 • Number of events 46 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	72.7% 168/231 • Number of events 304 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	36.0% 41/114 • Number of events 59 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	50.0% 13/26 • Number of events 16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Stomatitis	3.7% 5/136 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.8% 11/231 • Number of events 18 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 7/114 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Vomiting	41.9% 57/136 • Number of events 96 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 10/65 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	32.0% 74/231 • Number of events 126 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	18.4% 21/114 • Number of events 31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	38.5% 10/26 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Fatigue	48.5% 66/136 • Number of events 134 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	29.2% 19/65 • Number of events 37 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	47.6% 110/231 • Number of events 189 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	33.3% 38/114 • Number of events 53 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	50.0% 13/26 • Number of events 20 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Oedema peripheral	8.8% 12/136 • Number of events 15 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.5% 15/231 • Number of events 23 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.3% 6/114 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	19.2% 5/26 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Pain	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Urinary tract infection	14.7% 20/136 • Number of events 25 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.2% 6/65 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.3% 26/231 • Number of events 40 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Blood creatinine increased	8.1% 11/136 • Number of events 29 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.5% 15/231 • Number of events 32 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.6% 3/114 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Gamma-glutamyltransferase increased	5.1% 7/136 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	8.7% 20/231 • Number of events 48 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Neutrophil count decreased	16.9% 23/136 • Number of events 64 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	13.4% 31/231 • Number of events 79 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Platelet count decreased	25.0% 34/136 • Number of events 85 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	19.5% 45/231 • Number of events 132 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.5% 3/26 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations White blood cell count decreased	14.7% 20/136 • Number of events 42 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 5/65 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.5% 22/231 • Number of events 64 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Decreased appetite	22.1% 30/136 • Number of events 49 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	13.8% 9/65 • Number of events 12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	29.0% 67/231 • Number of events 94 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.8% 18/114 • Number of events 22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	23.1% 6/26 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Dehydration	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Hyperglycaemia	5.1% 7/136 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 5/65 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Hypokalaemia	8.1% 11/136 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 5/65 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.5% 15/231 • Number of events 26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Metabolism and nutrition disorders Hypomagnesaemia	11.0% 15/136 • Number of events 40 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	12.3% 8/65 • Number of events 18 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.8% 18/231 • Number of events 28 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.3% 6/114 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.5% 3/26 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Amnesia	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.5% 3/26 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Dizziness	19.1% 26/136 • Number of events 39 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.8% 7/65 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	18.6% 43/231 • Number of events 53 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.9% 9/114 • Number of events 12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Headache	38.2% 52/136 • Number of events 76 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.8% 7/65 • Number of events 12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	22.5% 52/231 • Number of events 97 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	12.3% 14/114 • Number of events 21 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	19.2% 5/26 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Neuropathy peripheral	9.6% 13/136 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 14/231 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.0% 8/114 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Insomnia	19.1% 26/136 • Number of events 36 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.2% 6/65 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	29.0% 67/231 • Number of events 88 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	8.8% 10/114 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.5% 3/26 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Cough	19.1% 26/136 • Number of events 36 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	18.2% 42/231 • Number of events 60 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.0% 8/114 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.9% 23/136 • Number of events 34 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	21.2% 49/231 • Number of events 62 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.5% 12/114 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Skin and subcutaneous tissue disorders Rash	10.3% 14/136 • Number of events 16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.9% 16/231 • Number of events 20 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Vascular disorders Deep vein thrombosis	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Vascular disorders Hypertension	27.9% 38/136 • Number of events 123 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 5/65 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	19.9% 46/231 • Number of events 207 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 4/26 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Catheter site pain	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
General disorders Mucosal inflammation	5.1% 7/136 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	8.2% 19/231 • Number of events 23 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Blood and lymphatic system disorders Leukopenia	8.1% 11/136 • Number of events 38 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.4% 17/231 • Number of events 52 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Paraesthesia	8.1% 11/136 • Number of events 31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Nervous system disorders Peripheral sensory neuropathy	5.1% 7/136 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Nasopharyngitis	15.4% 21/136 • Number of events 33 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	12.6% 29/231 • Number of events 40 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.6% 11/114 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Upper respiratory tract infection	11.0% 15/136 • Number of events 18 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 14/231 • Number of events 18 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Sinusitis	7.4% 10/136 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.5% 15/231 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Infections and infestations Bronchitis	4.4% 6/136 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.5% 15/231 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Weight decreased	6.6% 9/136 • Number of events 15 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Alanine aminotransferase increased	5.1% 7/136 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.6% 13/231 • Number of events 21 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Aspartate aminotransferase increased	5.1% 7/136 • Number of events 15 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.5% 15/231 • Number of events 27 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.8% 2/114 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Investigations Blood alkaline phosphatase increased	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.6% 13/231 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Arthralgia	21.3% 29/136 • Number of events 44 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	15.4% 10/65 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.7% 27/231 • Number of events 40 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	12.3% 14/114 • Number of events 20 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Back pain	21.3% 29/136 • Number of events 40 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	13.8% 9/65 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	14.3% 33/231 • Number of events 38 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	14.0% 16/114 • Number of events 38 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Pain in extremity	14.0% 19/136 • Number of events 27 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.2% 4/65 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.9% 16/231 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.4% 13/114 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Muscle spasms	11.8% 16/136 • Number of events 24 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 14/231 • Number of events 15 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Myalgia	11.0% 15/136 • Number of events 18 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.2% 6/65 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.1% 21/231 • Number of events 24 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.5% 12/114 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.1% 11/136 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.2% 12/231 • Number of events 23 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.6% 3/114 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 8/231 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 7/114 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Skin and subcutaneous tissue disorders Alopecia	11.0% 15/136 • Number of events 17 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.2% 6/65 • Number of events 6 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	8.7% 20/231 • Number of events 21 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.0% 8/114 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Skin and subcutaneous tissue disorders Pruritus	8.8% 12/136 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.2% 5/231 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.0% 8/114 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Skin and subcutaneous tissue disorders Photosensitivity reaction	8.1% 11/136 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.8% 25/231 • Number of events 37 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Skin and subcutaneous tissue disorders Petechiae	6.6% 9/136 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 11/136 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.9% 16/231 • Number of events 21 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	2.6% 3/114 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 7/136 • Number of events 9 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.2% 12/231 • Number of events 15 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Vascular disorders Hot flush	7.4% 10/136 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.6% 3/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.4% 24/231 • Number of events 43 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	5.3% 6/114 • Number of events 8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Anxiety	8.8% 12/136 • Number of events 27 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	10.8% 7/65 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.1% 21/231 • Number of events 27 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 5 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Psychiatric disorders Depression	6.6% 9/136 • Number of events 14 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 3 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 14/231 • Number of events 21 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Contusion	7.4% 10/136 • Number of events 12 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Injury, poisoning and procedural complications Fall	5.1% 7/136 • Number of events 10 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Palpitations	10.3% 14/136 • Number of events 19 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	11.7% 27/231 • Number of events 35 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Cardiac disorders Tachycardia	8.1% 11/136 • Number of events 13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	6.1% 14/231 • Number of events 20 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.88% 1/114 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.7% 2/26 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Renal and urinary disorders Dysuria	5.1% 7/136 • Number of events 11 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	1.5% 1/65 • Number of events 1 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	7.8% 18/231 • Number of events 30 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	4.4% 5/114 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Haemorrhoids	5.1% 7/136 • Number of events 7 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.1% 2/65 • Number of events 2 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/231 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/114 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/136 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/65 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	9.5% 22/231 • Number of events 25 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	3.5% 4/114 • Number of events 4 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/16 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/26 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/22 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/8 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/31 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).	0.00% 0/13 • All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).

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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