Trial Outcomes & Findings for Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations (NCT NCT04161391)

NCT ID: NCT04161391

Last Updated: 2024-06-13

Results Overview

Participants are eligible for DLT evaluation if they experience a DLT after at least one dose of TPX-0046, or do not experience a DLT after taking at least 75% of the doses expected during the DLT evaluation period. Some adverse events, graded using Common Terminology for Adverse Events (CTCAE) v. 5.0, for defining DLTs include: * Toxicities resulting in an excessive number of missed doses; * Hematologic: CTCAE grade ≥ 4 neutropenia, CTCAE grade ≥ 4 platelet count decrease, CTCAE grade ≥ 4 anemia, CTCAE grade ≥ 3 febrile neutropenia; * Renal: CTCAE grade ≥ 3 creatinine increase; * Hepatic: CTCAE grade ≥ 3 total bilirubin elevation; * Pancreatic: CTCAE grade 3 serum amylase or lipase increased with clinical symptoms or any grade ≥ serum amylase; * Cardiac: CTCAE grade ≥ 3; * Other AEs: CTCAE grade 3 vomiting or nausea that does not resolve to grade ≤ 1 within 4 days despite optimal anti-emetic therapy or any grade ≥ 4 vomiting

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: 28 days following the first highest dose of the dose regimen administered in Cycle 1
• Results posted on: 2024-06-13

Participant Flow

Participant milestones

Measure	10 mg QD TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent
Overall Study STARTED	4	4	4	8	3	3	7	6	2
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	4	4	8	3	3	7	6	2

Reasons for withdrawal

Measure	10 mg QD TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent
Overall Study Adverse Event	0	1	0	1	0	0	0	3	0
Overall Study Death	0	0	0	0	0	0	0	1	0
Overall Study Physician Decision	0	0	1	2	0	0	2	0	0
Overall Study Progressive Disease	4	3	3	5	3	3	5	2	2

Baseline Characteristics

Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations

Baseline characteristics by cohort

Measure	10 mg QD n=4 Participants TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID n=4 Participants TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD n=4 Participants TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD n=8 Participants TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID n=3 Participants TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD n=3 Participants TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID n=7 Participants TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD n=6 Participants TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID n=2 Participants TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	Total n=41 Participants Total of all reporting groups
Age, Continuous	59.5 Years STANDARD_DEVIATION 5.97 • n=5 Participants	58.0 Years STANDARD_DEVIATION 10.23 • n=7 Participants	60.8 Years STANDARD_DEVIATION 3.59 • n=5 Participants	60.1 Years STANDARD_DEVIATION 15.69 • n=4 Participants	59.3 Years STANDARD_DEVIATION 19.50 • n=21 Participants	64.7 Years STANDARD_DEVIATION 9.45 • n=10 Participants	62.7 Years STANDARD_DEVIATION 10.36 • n=115 Participants	60.5 Years STANDARD_DEVIATION 8.87 • n=24 Participants	61.5 Years STANDARD_DEVIATION 12.02 • n=42 Participants	60.8 Years STANDARD_DEVIATION 10.52 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	18 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	23 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	34 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	5 Participants n=42 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	28 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants

PRIMARY outcome

Timeframe: 28 days following the first highest dose of the dose regimen administered in Cycle 1

Population: DLT evaluable participants

Participants are eligible for DLT evaluation if they experience a DLT after at least one dose of TPX-0046, or do not experience a DLT after taking at least 75% of the doses expected during the DLT evaluation period. Some adverse events, graded using Common Terminology for Adverse Events (CTCAE) v. 5.0, for defining DLTs include:

• Toxicities resulting in an excessive number of missed doses;
• Hematologic: CTCAE grade ≥ 4 neutropenia, CTCAE grade ≥ 4 platelet count decrease, CTCAE grade ≥ 4 anemia, CTCAE grade ≥ 3 febrile neutropenia;
• Renal: CTCAE grade ≥ 3 creatinine increase;
• Hepatic: CTCAE grade ≥ 3 total bilirubin elevation;
• Pancreatic: CTCAE grade 3 serum amylase or lipase increased with clinical symptoms or any grade ≥ serum amylase;
• Cardiac: CTCAE grade ≥ 3;
• Other AEs: CTCAE grade 3 vomiting or nausea that does not resolve to grade ≤ 1 within 4 days despite optimal anti-emetic therapy or any grade ≥ 4 vomiting

Outcome measures

Measure	10 mg QD n=3 Participants TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID n=3 Participants TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD n=3 Participants TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD n=5 Participants TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD n=2 Participants TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID n=2 Participants TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD n=4 Participants TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID n=1 Participants TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent
Number of Participants With Dose Limiting Toxicities (DLTs) of TPX-0046	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 days following the first highest dose of the dose regimen administered in Cycle 1

Population: All treated participants

The MTD is defined as the highest dose level of TPX-0046 observed to cause a dose limiting toxicity (DLT) in fewer than 33% of the treated participants in the first treatment cycle (ie, Cycle 1, 28 days).

Outcome measures

Measure	10 mg QD n=41 Participants TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent
Maximum Tolerated Dose (MTD) of TPX-0046	32.54 mg	—	—	—	—	—	—	—	—

Adverse Events

10 mg QD

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

10 mg BID

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

20 mg QD

Serious events: 4 serious events

Other events: 4 other events

Deaths: 4 deaths

30 mg QD

Serious events: 7 serious events

Other events: 8 other events

Deaths: 4 deaths

20 mg BID

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

20 mg QD to 30 mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

20 mg QD to 20 mg BID

Serious events: 6 serious events

Other events: 7 other events

Deaths: 5 deaths

20 mg QD to 40 mg QD

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

10 mg QD to 10 mg BID

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	10 mg QD n=4 participants at risk TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID n=4 participants at risk TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD n=4 participants at risk TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD n=8 participants at risk TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID n=3 participants at risk TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD n=3 participants at risk TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID n=7 participants at risk TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD n=6 participants at risk TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID n=2 participants at risk TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent
Infections and infestations Urinary tract infection	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Vascular disorders Hypertension	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Vascular disorders Orthostatic hypotension	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Dizziness	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Paraesthesia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Syncope	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Neurogenic bladder	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Sepsis	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Endocrine disorders Cushingoid	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Food poisoning	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Ileus	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Asthenia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Malaise	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Multiple organ dysfunction syndrome	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations COVID-19 pneumonia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Cellulitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Coronavirus infection	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Gastroenteritis Escherichia coli	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Pneumonia	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Pneumonia bacterial	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Pneumonia viral	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).

Other adverse events

Measure	10 mg QD n=4 participants at risk TPX-0046 10 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg BID n=4 participants at risk TPX-0046 10 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD n=4 participants at risk TPX-0046 20 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	30 mg QD n=8 participants at risk TPX-0046 30 mg daily (QD) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg BID n=3 participants at risk TPX-0046 20 mg twice a day (BID) in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 30 mg QD n=3 participants at risk TPX-0046 20 mg daily (QD) for the first 14 days, then 30 mg daily in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 20 mg BID n=7 participants at risk TPX-0046 20 mg daily (QD) for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	20 mg QD to 40 mg QD n=6 participants at risk TPX-0046 20 mg (daily) QD for the first 14 days, then 40 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent	10 mg QD to 10 mg BID n=2 participants at risk TPX-0046 10 mg daily (QD) for the first 14 days, then 20 mg in 28-day continuous cycles until disease progression, unacceptable toxicity, the ability to move to alternative care is identified, or withdrawal of consent
Eye disorders Dry eye	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Salivary hypersecretion	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Nail pigmentation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Papule	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Vascular disorders Aortic aneurysm	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Vascular disorders Hypertension	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Vascular disorders Hypotension	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Vascular disorders Orthostatic hypotension	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Cardiac disorders Left ventricular dysfunction	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Cardiac disorders Palpitations	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Cardiac disorders Sinus bradycardia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Cardiac disorders Tachycardia	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Cardiac disorders Ventricular tachycardia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Ear and labyrinth disorders Vertigo	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Endocrine disorders Hypothyroidism	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Blepharitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Cataract	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Cataract subcapsular	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Chorioretinopathy	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Macular oedema	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Serous retinopathy	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Subretinal fluid	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Vision blurred	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Visual acuity reduced	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Eye disorders Visual impairment	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Ascites	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Breath odour	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Constipation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Dry mouth	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Eructation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Melaena	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Mouth ulceration	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Nausea	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Paraesthesia oral	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Gastrointestinal disorders Vomiting	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Asthenia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Catheter site pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Chills	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Fatigue	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Feeling abnormal	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Feeling hot	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Gait disturbance	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Generalised oedema	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Malaise	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Mucosal inflammation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Nodule	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Non-cardiac chest pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Oedema peripheral	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Crystal urine present	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Pyrexia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
General disorders Temperature intolerance	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Hepatobiliary disorders Hyperbilirubinaemia	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Wound	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Bronchitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Candida infection	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Catheter site infection	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Cellulitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Chest wall abscess	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Hordeolum	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Infectious pleural effusion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Onychomycosis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Oral candidiasis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Orchitis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Paronychia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Pneumonia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Tinea cruris	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Infections and infestations Urinary tract infection	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Joint injury	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Injury, poisoning and procedural complications Skin injury	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Alanine aminotransferase increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Amylase increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Bacterial test	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Blood albumin decreased	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Blood bilirubin increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Blood chloride decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Blood creatinine increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Cardiac murmur	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Cells in urine	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Ejection fraction decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Escherichia test positive	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Haematocrit decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Haemoglobin decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations International normalised ratio increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Lipase increased	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Lymphocyte count decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Neutrophil count decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Platelet count decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Red blood cell count decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Red blood cell count increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Troponin T increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Urinary sediment present	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Urine ketone body present	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Urine leukocyte esterase positive	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Urine output decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Weight decreased	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations Weight increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations White blood cell count decreased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Investigations White blood cell count increased	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Increased appetite	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Malnutrition	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Ataxia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Balance disorder	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Burning sensation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Dizziness	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	75.0% 3/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Dysgeusia	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Headache	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Hypersomnia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Memory impairment	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Neuralgia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Paraesthesia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Presyncope	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Taste disorder	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Nervous system disorders Tremor	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Psychiatric disorders Agitation	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Psychiatric disorders Confusional state	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	50.0% 2/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Psychiatric disorders Delirium	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Psychiatric disorders Insomnia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Chromaturia	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Chronic kidney disease	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Dysuria	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Micturition urgency	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Nephropathy	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Oliguria	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Proteinuria	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Renal failure	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Renal and urinary disorders Urinary retention	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 1/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/4 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	16.7% 1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately an average of 6 months and a maximum of 27 months).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER