Trial Outcomes & Findings for A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03 (NCT NCT03420781)

NCT ID: NCT03420781

Last Updated: 2021-12-22

Results Overview

Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

467 participants

Primary outcome timeframe

Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study

Results posted on

2021-12-22

Participant Flow

Participants who completed RLM-MD-01 \[NCT03285308\] or RLM-MD-02 \[NCT03426345\] were eligible for enrollment.

Participant milestones

Participant milestones
Measure	Treatment Period: Placebo Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Treatment Period (40 Weeks) STARTED	236	231	0	0	0
Treatment Period (40 Weeks) Safety Population	235	231	0	0	0
Treatment Period (40 Weeks) COMPLETED	92	105	0	0	0
Treatment Period (40 Weeks) NOT COMPLETED	144	126	0	0	0
RW Period: 6 Weeks (Week 41 to Week 46) STARTED	0	0	91	59	43
RW Period: 6 Weeks (Week 41 to Week 46) COMPLETED	0	0	85	54	38
RW Period: 6 Weeks (Week 41 to Week 46) NOT COMPLETED	0	0	6	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Period: Placebo Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Treatment Period (40 Weeks) Adverse Event	1	6	0	0	0
Treatment Period (40 Weeks) Lack of Efficacy	1	1	0	0	0
Treatment Period (40 Weeks) Withdrawal by Subject	22	16	0	0	0
Treatment Period (40 Weeks) Lost to Follow-up	10	6	0	0	0
Treatment Period (40 Weeks) Death	2	2	0	0	0
Treatment Period (40 Weeks) Physician Decision	3	4	0	0	0
Treatment Period (40 Weeks) Protocol Deviation	0	2	0	0	0
Treatment Period (40 Weeks) Study Terminated by the Sponsor	101	89	0	0	0
Treatment Period (40 Weeks) Site Terminated by the Sponsor	1	0	0	0	0
Treatment Period (40 Weeks) Reason Not Specified	3	0	0	0	0
RW Period: 6 Weeks (Week 41 to Week 46) Adverse Event	0	0	0	2	0
RW Period: 6 Weeks (Week 41 to Week 46) Withdrawal by Subject	0	0	0	0	2
RW Period: 6 Weeks (Week 41 to Week 46) Study Terminated by the Sponsor	0	0	6	3	3

Baseline Characteristics

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Period: Placebo n=236 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Total n=467 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 11.11 • n=5 Participants	56.2 years STANDARD_DEVIATION 11.51 • n=7 Participants	55.9 years STANDARD_DEVIATION 11.30 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	166 Participants n=7 Participants	328 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	65 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	83 Participants n=5 Participants	82 Participants n=7 Participants	165 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants n=5 Participants	149 Participants n=7 Participants	302 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	37 Participants n=5 Participants	21 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	175 Participants n=5 Participants	183 Participants n=7 Participants	358 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study

Population: Modified-intent-to-treat (mITT) Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period Baseline	24.9 score on a scale Standard Deviation 5.65	24.8 score on a scale Standard Deviation 6.28	—	—	—
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period Change from Baseline to Week 12	-11.9 score on a scale Standard Deviation 9.43	-11.2 score on a scale Standard Deviation 9.00	—	—	—

PRIMARY outcome

Timeframe: Week 6 to Week 12

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period	29.4 percentage of participants	21.4 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period	46.0 percentage of participants	43.2 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period	40.4 percentage of participants	39.7 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period	38.3 percentage of participants	38.4 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period	36.6 percentage of participants	36.2 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period Baseline	24.9 score on a scale Standard Deviation 5.65	24.8 score on a scale Standard Deviation 6.28	—	—	—
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period Change from Baseline to Week 40	-13.3 score on a scale Standard Deviation 10.22	-12.3 score on a scale Standard Deviation 9.20	—	—	—

SECONDARY outcome

Timeframe: Week 37 to Week 40

Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period	19.1 percentage of participants	18.8 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)

The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=229 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period Baseline	6.8 vomiting episodes per week Standard Deviation 11.09	7.3 vomiting episodes per week Standard Deviation 11.52	—	—	—
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period Change from Baseline to Week 40	-1.8 vomiting episodes per week Standard Deviation 17.51	-5.4 vomiting episodes per week Standard Deviation 11.87	—	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)

Population: RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=91 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=58 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period Baseline	25.7 score on a scale Standard Deviation 5.65	25.7 score on a scale Standard Deviation 6.25	24.4 score on a scale Standard Deviation 5.47	—	—
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period Change from Baseline to Week 46	-13.4 score on a scale Standard Deviation 10.45	-12.5 score on a scale Standard Deviation 9.71	-12.5 score on a scale Standard Deviation 9.35	—	—

SECONDARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)

Population: RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the given timepoint.

The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=91 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=58 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period Baseline	6.1 vomiting episodes per week Standard Deviation 7.01	9.9 vomiting episodes per week Standard Deviation 11.92	4.2 vomiting episodes per week Standard Deviation 4.73	—	—
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period Change from Baseline to Week 46	-1.8 vomiting episodes per week Standard Deviation 18.40	-7.3 vomiting episodes per week Standard Deviation 10.23	-1.8 vomiting episodes per week Standard Deviation 6.12	—	—

SECONDARY outcome

Timeframe: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)

Population: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=91 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)	129 Participants	131 Participants	18 Participants	12 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 46 weeks

Clinical Laboratory values included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=91 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Protein, Total (g/L): >1.1×ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)	7 Participants	7 Participants	4 Participants	0 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hemoglobin [grams (g)/L]: <0.9×LLN	13 Participants	14 Participants	5 Participants	1 Participants	4 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN	2 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN	6 Participants	4 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Red Blood Cell Count (10^12/L): >1.1×ULN	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Red Blood Cell Count (10^12/L): <0.9×LLN	4 Participants	8 Participants	4 Participants	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results White Blood Cell Count (10^9/L): <0.7×LLN	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Albumin (g/L): <0.9×LLN	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Alkaline Phosphatase (U/L): >=3×ULN	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN	3 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Blood Urea Nitrogen (mmol/L): >1.2×ULN	29 Participants	20 Participants	8 Participants	4 Participants	4 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Calcium (mmol/L): >1.1×ULN	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Calcium (mmol/L): <0.9×LLN	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Chloride (mmol/L): <0.9×LLN	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Cholesterol, Total, Fasting (mmol/L): >1.6×ULN	4 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Creatinine (μmol/L): >1.3×ULN	22 Participants	16 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN	41 Participants	33 Participants	9 Participants	9 Participants	4 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glycohemoglobin A1C: Increase of >=0.5%	134 Participants	138 Participants	62 Participants	26 Participants	28 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Potassium (mmol/L): <0.9×LLN	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Protein, Total (g/L): <0.9×LLN	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Triglycerides, Fasting (mmol/L): >=3×ULN	9 Participants	11 Participants	4 Participants	4 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Uric Acid (Urate) (μmol/L): >1.1×ULN	31 Participants	31 Participants	5 Participants	3 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Uric Acid (Urate) (μmol/L): <0.9×LLN	3 Participants	4 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Eosinophils Absolute Cell Count [10^9/liter(L)]: >3×Upper Limit of Normal Value (ULN)	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hematocrit (RATIO): >1.1×ULN	1 Participants	2 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Mean Corpuscular Volume (fL): <0.9×LLN	4 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) (mmol)/L: >0.9×LLN	6 Participants	9 Participants	2 Participants	4 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN	14 Participants	9 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glycohemoglobin A1C: Increase of >=1%	134 Participants	138 Participants	62 Participants	26 Participants	28 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Phosphorus (mmol/L): >1.1×ULN	10 Participants	12 Participants	4 Participants	4 Participants	4 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Phosphorus (mmol/L): <0.9×LLN	4 Participants	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 46 weeks

Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=91 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Number of Participants With Clinically Meaningful Trends for Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 46 weeks

A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=235 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=91 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 46 weeks

Outcome measures

Outcome measures
Measure	Treatment Period: Placebo n=224 Participants Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=223 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=91 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 Participants Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)	134 Participants	138 Participants	62 Participants	26 Participants	28 Participants

SECONDARY outcome

Timeframe: Up to 46 weeks

Population: Due to limitations at the vendor's end, the final analysis data could not be obtained.

A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Period: Placebo

Serious events: 24 serious events

Other events: 18 other events

Deaths: 3 deaths

Treatment Period: Relamorelin 10 μg

Serious events: 20 serious events

Other events: 27 other events

Deaths: 2 deaths

Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Period: Placebo n=235 participants at risk Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 participants at risk Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg n=91 participants at risk Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 participants at risk Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 participants at risk Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Cardiac disorders Myocardial infarction	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.7% 1/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Postinfarction angina	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.7% 1/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Pancreatitis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.87% 2/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Abdominal pain	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Hiatus hernia	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Duodenitis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Vomiting	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Gastrointestinal disorders Intestinal ischaemia	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
General disorders Chest pain	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
General disorders Non-cardiac chest pain	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.1% 1/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Osteomyelitis	0.85% 2/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Pneumonia	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.1% 1/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Septic shock	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Urinary tract infection	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Abscess limb	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Atypical pneumonia	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations COVID-19	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.1% 1/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Cellulitis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.1% 1/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Cellulitis gangrenous	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Diverticulitis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Localised infection	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Pyelonephritis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Staphylococcal infection	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Bronchitis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Gastroenteritis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Gastroenteritis viral	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Infected dermal cyst	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Pyelonephritis acute	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Renal abscess	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Sepsis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Upper respiratory tract infection	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Infections and infestations Urosepsis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Injury, poisoning and procedural complications Chemical poisoning	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Injury, poisoning and procedural complications Fall	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	2.3% 1/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Investigations Blood pressure increased	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.85% 2/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.3% 3/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Metabolism and nutrition disorders Hypoglycaemia	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Metabolism and nutrition disorders Metabolic acidosis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	2.3% 1/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma metastatic	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Nervous system disorders Cerebrovascular accident	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Nervous system disorders Transient ischaemic attack	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Nervous system disorders Hemiparesis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Nervous system disorders Hypoaesthesia	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Nervous system disorders Syncope	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.7% 1/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	2.3% 1/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	2.3% 1/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Psychiatric disorders Suicidal ideation	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Psychiatric disorders Confusional state	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Psychiatric disorders Psychogenic tremor	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Renal and urinary disorders Acute kidney injury	1.7% 4/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.3% 3/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	2.3% 1/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	1.1% 1/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Skin and subcutaneous tissue disorders Skin ulcer	0.85% 2/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Skin and subcutaneous tissue disorders Dermatitis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Vascular disorders Deep vein thrombosis	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Vascular disorders Hypertensive urgency	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Vascular disorders Orthostatic hypotension	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Vascular disorders Peripheral vascular disorder	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Vascular disorders Accelerated hypertension	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	2.3% 1/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Coronary artery disease	1.3% 3/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.43% 1/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Cardiac failure congestive	0.85% 2/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Acute myocardial infarction	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Atrial fibrillation	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Atrial tachycardia	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Cardiac disorders Cardiomyopathy	0.43% 1/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.

Other adverse events

Other adverse events
Measure	Treatment Period: Placebo n=235 participants at risk Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.	Treatment Period: Relamorelin 10 μg n=231 participants at risk Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.	Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg n=91 participants at risk Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg n=59 participants at risk Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.	Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo n=43 participants at risk Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Infections and infestations Urinary tract infection	5.5% 13/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	6.9% 16/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
Metabolism and nutrition disorders Hyperglycaemia	3.0% 7/235 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	5.2% 12/231 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/91 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/59 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.	0.00% 0/43 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) All-Cause Mortality: all randomized participants. Adverse Events: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period; RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER